Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax

Malaria Clinical Trial

— CQ+PQ  

Official title:

Monitoring Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Based on Clinical, Parasitologic and Hematologic Parameters in Shecha Health Center: Open Label Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06044805
• Other study ID #: EPHI-IRB-294-2
• Status: Completed
• Phase: Phase 4
• Start date: December 19, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: September 2023
• Source: Wollega University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia. The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter. Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria. This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.

Description:

The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia. The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter. Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria. This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 15, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• Age > 6 months
• Slide confirmed infection with P. vivax with > 250 asexual forms/µl
• Lives within 5 km of the enrolling health facility
• Weight = 5.0 kg
• Ability to swallow oral medication
• Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule
• Informed consent from patient or from a parent or guardian in the case of children

Exclusion Criteria:

• Sever malaria with complication sign and symptoms
• Signs or symptoms of severe malnutrition, defined as weight-for-age = 3 standard deviations below the mean, symmetrical edema involving at least the feet, or mid-upper arm circumference <100 cm for children less than five years of age
• Mixed plasmodium infection
• Severe anemia, defined as hemoglobin (Hb) < 5 g/dl
• Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration)
• Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
• Positive pregnancy test or breastfeeding
• Unable or unwilling to take contraceptives for women of child-bearing age
• Children weighing less than 5 kilograms
• History of hypersensitivity reaction to any medication tested or used as an alternative treatment
• Participants with history of prolonged QT conditions
• Taking regular medication, which may interfere with antimalarial pharmacokinetics or efficacy

Related Conditions & MeSH terms

• Chloroquine
• Efficacy
• Malaria
• Malaria, Vivax
• Vivax Malaria

Intervention

Drug:
• Chloroquine
Total of 25mg base per kg over 3 days (10 mg base/kg on Days 0 and 1, 5 mg base/kg on Day 2)
• Primaquine
Primaquine: 7.5 mg base tablet. Medication given as 0.25mg/kg daily for 14 days.

Locations

Country	Name	City	State
Ethiopia	Shecha Health Center	Arba Minch	South Ethiopia

Sponsors (2)

Lead Sponsor	Collaborator
Dinka Dugassa	Ethiopian Public Health Institute

Country where clinical trial is conducted

Ethiopia, 

References & Publications (4)

Bekele F, Fekadu G, Bekele K, Dugassa D, Sori J. Drug-related problems among patients with infectious disease admitted to medical wards of Wollega University Referral Hospital: Prospective observational study. SAGE Open Med. 2021 Jan 22;9:2050312121989625 — View Citation

Fekadu G, Bekele F, Tolossa T, Fetensa G, Turi E, Getachew M, Abdisa E, Assefa L, Afeta M, Demisew W, Dugassa D, Diriba DC, Labata BG. Impact of COVID-19 pandemic on chronic diseases care follow-up and current perspectives in low resource settings: a narr — View Citation

Fekadu G, Dugassa D, Negera GZ, Woyessa TB, Turi E, Tolossa T, Fetensa G, Assefa L, Getachew M, Shibiru T. Self-Medication Practices and Associated Factors Among Health-Care Professionals in Selected Hospitals of Western Ethiopia. Patient Prefer Adherence. 2020 Feb 20;14:353-361. doi: 10.2147/PPA.S244163. eCollection 2020. — View Citation

Fekadu G, Turi E, Kasu T, Bekele F, Chelkeba L, Tolossa T, Labata BG, Dugassa D, Fetensa G, Diriba DC. Impact of HIV status and predictors of successful treatment outcomes among tuberculosis patients: A six-year retrospective cohort study. Ann Med Surg (L — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early treatment failure [Time Frame: within the first 3 days]	Danger signs or severe malaria on day 1, day 2 or day 3 in the presence of parasitemia;Parasitemia on day 2 higher than on day 0, irrespective of axillary temperature;Parasitemia on day 3 with axillary temperature =37.5 ºC;Parasitemia on day 3 =25% of count on day 0.	within the first 3 days
Primary	Late Clinical Failure (LCF)	Danger signs or severe malaria in the presence of parasitemia on any day between day 4 and 42 in patients who did not previously meet any of the criteria of Early Treatment Failure; Presence of parasitemia on any day between 4 and day 42 with axillary temperature =37.5 °C (or history of fever) in patients who did not previously meet any of the criteria of Early Treatment Failure.	42 days
Primary	Late Parasitological Failure (LPF)	Presence of parasitemia on any day between day 7 and day 42 and axillary temperature <37.5 ºC in patients who did not previous meeting any of the criteria of Early Treatment Failure or Late Clinical Failure.	42 days
Primary	Adequate Clinical and Parasitological Response (ACPR)	Absence of parasitemia on day 42 irrespective of axillary temperature, in patients who did not previously meet any of the criteria of Early Treatment Failure, Late Clinical Failure, or Late Parasitological Failure.	42 days
Secondary	The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.	This study's secondary goal was to calculate the parasite clearance rate based on parasite clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.	42 days
Secondary	The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.	This study's secondary goal was to calculate the gametocyte clearance rate based on gametocyte clearance time. Using hours, days, weeks, and months, parasite clearance time is calculated.	42 days
Secondary	The secondary outcome of this study is determining fever clearance rate based on fever clearance time.	Calculating the fever clearance rate based on fever clearance time was the secondary outcome of this clinical trial. Fever clearance time is calculated using hours, days, weeks, and months. Temperatures less than 37.5 degrees celsius (T 37.5oC) are deemed to be fever-free(fever cleared) while temperatures greater than or equal to 37.5 degrees celsius (T>37.5oC) are classified as having fever (fever not cleared).	42 days
Secondary	The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.	Calculating the mean hemoglobin change overtime in the 42 study period based on hemoglobin concentration at D0, D14, D28 and D42 was the secondary outcome of this clinical trial. Milligrammes per deciliter are used to measure the concentration of haemoglobin.	42 days
Secondary	The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.	This study's secondary goal was evaluating the incidence of adverse events in 42 follow-up period.	42 days