Malaria, Falciparum Clinical Trial
Official title:
A Phase 2/3, Randomized, Comparative, Double Blind Trial Of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia
Verified date | October 2008 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.
Status | Terminated |
Enrollment | 32 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Females and males >=18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites/mL b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours - Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection) - Positive rapid diagnostic test (Binax NOW ICT) for P. falciparum - Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study Exclusion Criteria: - Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density > 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy - Pregnant or breast-feeding women - History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine - Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia) - History of epilepsy or psoriasis - History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study - Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) serum creatinine > 2.0 x ULN b.) ALT and/or AST > 3 x ULN - Inability to swallow oral medication in tablet form - Treatment with other investigational drugs within 30 Days prior to enrollment into the study - Alcohol and/or any other drug abuse - Requirement to use medication during the study that might interfere with the evaluation of the study drug (nelfinavir, digoxin, ergot alkaloids, terfenadine, cyclosporine, hexobarbital and phenytoin) - Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug - Inability to comprehend and/or unwillingness follow the study protocol - Intentions to leave the vicinity of the trial site in the next 42 days - Prior participation in this study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | parasite clearance | |||
Secondary | tolerability and safety |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02329301 -
Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia
|
N/A | |
Recruiting |
NCT01944189 -
Artemether/ Lumefantrine: A Study of the Effect of Local Food on Pharmacokinetics and Population Pharmacokinetics
|
Phase 4 | |
Terminated |
NCT01442168 -
Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
|
Phase 1/Phase 2 | |
Completed |
NCT01325974 -
Time to Become Negative of Three Rapid Diagnostic Tests for Malaria
|
N/A | |
Completed |
NCT00375128 -
Sporozoite Challenge of Polyprotein Vaccinees
|
Phase 1/Phase 2 | |
Terminated |
NCT00374205 -
Randomized Trial on Effectiveness of ACTs in Ghana
|
Phase 4 | |
Completed |
NCT04609098 -
Single Low Dose Tafenoquine to Reduce P. Falciparum Transmission in Mali (NECTAR2)
|
Phase 2 | |
Completed |
NCT02851108 -
Methylene Blue Against Falciparum Malaria in Burkina Faso
|
Phase 2 | |
Completed |
NCT02434952 -
Safety and Tolerability of Low Dose Primaquine
|
Phase 4 | |
Terminated |
NCT02281344 -
MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
|
Phase 1 | |
Completed |
NCT01213966 -
Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection
|
Phase 2 | |
Completed |
NCT00479206 -
Artemisinin Resistance in Cambodia
|
N/A | |
Completed |
NCT00126906 -
Prevention of Malaria During Pregnancy Using Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine: Malawi
|
N/A | |
Completed |
NCT01019408 -
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan
|
Phase 4 | |
Completed |
NCT00529867 -
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
|
Phase 4 | |
Completed |
NCT00137553 -
The Efficacy of Re-treatment With Sulfadoxine-pyrimethamine in Children
|
Phase 4 | |
Completed |
NCT02637128 -
In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria
|
Phase 4 | |
Completed |
NCT01222962 -
Food Interaction Study on the Pharmacokinetics of Eurartesimâ„¢ (DHA and PQP)in Healthy Male Adult Volunteers
|
Phase 1 | |
Unknown status |
NCT00152204 -
The Community Effectiveness of IPTi in Southern Tanzania
|
Phase 3 | |
Completed |
NCT00137514 -
Chloroquine and Amodiaquine for Treatment of Malaria in Children
|
Phase 4 |