Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02497612
Other study ID # DRI12805
Secondary ID U1111-1155-7960
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 25, 2015
Est. completion date September 23, 2019

Study information

Verified date March 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.


Description:

Total duration was 63 days for each participant.


Recruitment information / eligibility

Status Terminated
Enrollment 377
Est. completion date September 23, 2019
Est. primary completion date September 23, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months to 69 Years
Eligibility Inclusion criteria: Male or female participant aged greater than (>) 6 months old and <70 years old: - Cohort 1 = 14 years < age <70 years and body weight greater than or equal to (>=) 35 kilogram (kg). - Cohort 2 = 5 years < age less than or equal to (<=) 14 years. - Cohort 3 = 2 years < age <=5 years. - Cohort 4 = 6 months < age <=2 years. Body weight >=5 kg and <=90 kg. Presence of mono-infection by Plasmodium falciparum with: - Fever, as defined by axillary temperature >=37.5 degrees Celsius (°C) or oral/rectal/tympanic temperature >=38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, - Microscopically (blood smear) confirmed parasite infection, ranging from 1000 to 100 000 asexual parasites/microliter of blood. Informed consent form signed by the participant or by the legally acceptable representative of the minor participant. Exclusion criteria: Presence of severe malaria. Anti-malarial treatment: - With piperaquine-based compound, mefloquine, naphthoquine or sulphadoxine/pyrimethamine (SP) within the previous 6 weeks (after their inhibition of new infections had fallen below 50%). - With amodiaquine or chloroquine within the previous 4 weeks. - With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days. - With any herbal products or traditional medicines, within the past 7 days. Known history or evidence of clinically significant disorders. Previous treatment within 5 times the half-life or within the last 14 days, whichever the longest which are: P-glycoprotein substrates, Cytochrome P450 (CYP) 2D6 main substrates and/or strong CYP2C or CYP3A inhibitors and/or moderate inhibitors but inhibiting both CYP2C and CYP3A and/or CYP inducers. Mixed plasmodium infection. Severe vomiting. Severe malnutrition. Laboratory parameters with clinically significant abnormalities and/or reaching critical values. For Liver Function Test. Aspartate aminotransferase (>2 [upper limit of normal] ULN), or alanine aminotransferase (>2 ULN) or total bilirubin >1.5 ULN. Presence of Hepatitis A Immunoglobulin M, Hepatitis B surface antigen or Hepatitis C antibody. Had received an investigational drug within the past 4 weeks. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance. Measles and yellow fever vaccine injection within the last 15 days and or planned for the 28 days after randomization. Female participant of child bearing potential not willing to use an effective contraceptive(s) method(s) for the duration of the study. Positive serum or urine beta-human chorionic gonadotropin pregnancy test at study screening for female participants of childbearing potential. Breastfeeding women. Male participant having a partner of child bearing potential not willing to use an effective method of birth control during the study treatment period. Splenectomized participants or presence of surgical scar on left hypochondrium. Participant unable to drink. Known history of hypersensitivity, allergic or anaphylactoid reactions to ferroquine or other amino-quinolines or to OZ439 or OZ277 or to any of the excipients. Family history of sudden death or of congenital prolongation of the Corrected QT (QTc) interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval e.g., participants with a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia. QTc using Fridericia's formula >450 millisecond at screening or pre-dose. Hypokalemia (<3.5 millimoles per liter [mmol/L]), hypocalcemia (<2.0 mmol/L) or hypomagnesemia (<0.5 mmol/L) at screening or pre-dose. Any treatment known to induce a lengthening of QT interval. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design


Intervention

Drug:
Ferroquine SSR97193
Pharmaceutical form:Capsules Route of administration: oral
Artefenomel
Pharmaceutical form:Granules for suspension Route of administration: oral
Other:
Placebo
Capsules. Placebo capsules were used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No participant received placebo only.

Locations

Country Name City State
Benin Investigational Site Number 204001 Cotonou
Burkina Faso Investigational Site Number 854002 Comoé
Burkina Faso Investigational Site Number 854003 Niangoloko
Burkina Faso Investigational Site Number 854001 Ouagadougou
Gabon Investigational Site Number 266002 Lambaréné
Gabon Investigational Site Number 266001 Libreville
Kenya Investigational Site Number 404003 Kisumu
Kenya Investigational Site Number 404002 Siaya
Mozambique Investigational Site Number 508001 Chokwé
Uganda Investigational Site Number 800002 Tororo
Vietnam Investigational Site Number 704003 Binh Phuoc
Vietnam Investigational Site Number 704004 Gia Lai

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Medicines for Malaria Venture

Countries where clinical trial is conducted

Benin,  Burkina Faso,  Gabon,  Kenya,  Mozambique,  Uganda,  Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) at Day 28: African <=5 Years Per Protocol Population at Day 28 (PP28) ACPR: negative parasitemia at Day 28, irrespective of axillary temperature(AT), in participants not meeting any criteria of early therapy failure (ETF):Danger signs (DS)/severe malaria (SM) at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count >Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5 degree Celsius (°C); or parasite count on Day 3>=25 percent (%) on Day 0, or late clinical failure(LCF):DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT>=37.5°C between Day 4 and 28, or late parasitological failure (LPF):presence of parasitemia between Day 7 and 28 and AT<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection. In data table, "overall number of participants analyzed"=participants evaluable for this outcome measure. Day 28
Secondary Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: African >5 Years Per Protocol Population at Day 28 (A5PP28) ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure. Day 28
Secondary Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: Asian PP Population at Day 28 (APP28) ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure. Day 28
Secondary Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP Population at Day 42 (PP42) ACPR: negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT >=37.5°C between Day 4 and 42, or LPF: presence of parasitemia between Day 7 and 42 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure. Day 42
Secondary Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP Population at Day 63 (PP63) ACPR: negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT >=37.5°C between Day 4 and 63, or LPF: presence of parasitemia between Day 7 and 63 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure. Day 63
Secondary Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28: African <=5 Years PP28 Population ACPR was defined as negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28 or, LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish re-infection (new clone of parasite) or recrudescence. Day 28
Secondary Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP42 Population ACPR was defined as negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT >=37.5°C between Day 4 and 42 or, LPF: presence of parasitemia between Day 7 and 42 and AT <37.5°C or having rescue therapy for malaria PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence. Day 42
Secondary Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP63 Population Crude ACPR was defined as negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT >=37.5°C between Day 4 and 63 or, LPF: presence of parasitemia between Day 7 and 63 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence. Day 63
Secondary Time to Re-emergence Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Re-emergence was confirmed by microscopy (positive blood smear). Kaplan-Maier method was used for estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored. Up to Day 63
Secondary Time to Recrudescence Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Kaplan-Maier method was used for estimation. Up to Day 63
Secondary Time to Re-infection Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differs from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Kaplan-Maier method was used for estimation. Up to Day 63
Secondary Parasite Clearance Time (PCT): African <=5 Years PP Population PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, in the data table "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored. From the start of study drug administration up to the time of the first negative film (up to Day 63)
Secondary Parasite Clearance Time: African >5 Years PP Population PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored. From the start of study drug administration up to the time of the first negative film (up to Day 63)
Secondary Parasite Clearance Time: Asian PP Population PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored. From the start of study drug administration up to the time of the first negative film (up to Day 63)
Secondary Fever Clearance Time (FCT): African <=5 Years PP Population FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first assessment. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation. From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)
Secondary Fever Clearance Time: African >5 Years PP Population FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation. From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)
Secondary Fever Clearance Time: Asian PP Population FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored. From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)
Secondary Parasite Reduction Ratio (PRRlog10) at 24 Hours and 48 Hours: African <=5 Years PP Population The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively. 24 and 48 hours post dose
Secondary Parasite Reduction Ratio at 24 Hours and 48 Hours: African >5 Years PP Population The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively. 24 and 48 hours post dose
Secondary Parasite Reduction Ratio at 24 Hours and 48 Hours: Asian PP Population The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively. 24 and 48 hours post dose
Secondary Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI) An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of the first dose of double-blind drug administration up to the Day 63. AE of special interest (AESI) was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. From Baseline up to Day 63
Secondary Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Artefenomel Cmax is the maximum observed plasma concentration of artefenomel. 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Secondary Pharmacokinetics: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Artefenomel Area under the plasma concentration versus time curve from time zero to infinity. 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Secondary Pharmacokinetics (PK): Apparent Total Clearance of Artefenomel From Plasma After Oral Administration Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Secondary Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration (Vss/F) of Artefenomel Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Secondary Pharmacokinetics: Maximum Observed Plasma Concentration of Ferroquine (Cmax) Cmax is the maximum observed plasma concentration of Ferroquine. 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Secondary Pharmacokinetics: Area Under the Curve From Time 0 to Day 28 (AUC0-day28) of Ferroquine Area under the plasma concentration versus time curve from time 0 to Day 28 (i.e. 672 hours). 2, 4, 6, 8, 12, 24, 48, 168, 336 and 672 hours postdose
Secondary Pharmacokinetics: Apparent Total Clearance of Ferroquine From Plasma After Oral Administration Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Secondary Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration of Ferroquine Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Secondary Pharmacokinetics: Blood/Plasma Ratio for Ferroquine and Its Active Metabolite SSR97213 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
See also
  Status Clinical Trial Phase
Recruiting NCT05400655 - Anti-malaria MAb in Kenyan Children Phase 2
Completed NCT02773979 - PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States Phase 1
Completed NCT03660839 - Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria Phase 2
Terminated NCT00988507 - Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria Phase 2
Recruiting NCT05750459 - Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria Phase 4
Completed NCT02020330 - Optimising Operational Use of Artemether-lumefantrine Comparing 3 Day Versus 5 Day Phase 3
Completed NCT05816330 - L9LS MAb in Malian Adults Phase 2
Completed NCT02353494 - Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria N/A
Completed NCT00744133 - Malaria Challenge With NF54 Strain Phase 1
Active, not recruiting NCT05304611 - Anti-malaria MAb in Malian Children Phase 2
Completed NCT03014258 - A Systems Biology Approach to Malaria Immunity Phase 1
Completed NCT03168854 - Trial to Evaluate the Safety, Immunogenicity and Protective Efficacy of Three or Five Administrations of GAP3KO Sporozoites Phase 1
Completed NCT00371189 - Adenovirus Vaccine for Malaria Phase 1
Not yet recruiting NCT05025761 - Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Myanmar N/A
Completed NCT00379821 - Chloroquine Alone or in Combination for Malaria in Children in Malawi Phase 3
Completed NCT04329104 - Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali Phase 2
Completed NCT03589794 - rCSP/AP10-602 [GLA-LSQ] Vaccine Trial Phase 1
Completed NCT02780154 - PfSPZ Challenge in Non-immune Adults in Baltimore, USA Phase 1
Completed NCT02143934 - Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity Phase 4
Completed NCT02663700 - Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso Phase 1