Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
- Conditions
- MalariaVivax MalariaChloroquineEfficacy
- Interventions
- Registration Number
- NCT06044805
- Lead Sponsor
- Dinka Dugassa
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Therapeutic Efficacy of Chloroquine Plus Primaquine Chloroquine An invivo single arm trial. Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1(10mg/kg) and 2 (5mg/kg). Total dose, 25 mg base/kg. Primaquine - it was given once a day (0.25 mg/kg) for fourteen days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg. The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes. Therapeutic Efficacy of Chloroquine Plus Primaquine Primaquine An invivo single arm trial. Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1(10mg/kg) and 2 (5mg/kg). Total dose, 25 mg base/kg. Primaquine - it was given once a day (0.25 mg/kg) for fourteen days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg. The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
- Primary Outcome Measures
Name Time Method Late Clinical Failure (LCF) 42 days 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.
Adequate Clinical and Parasitological Response (ACPR) 42 days 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.
Early treatment failure [Time Frame: within the first 3 days] 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.
Late Parasitological Failure (LPF) 42 days 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.
- Secondary Outcome Measures
Name Time Method The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period. 42 days This study's secondary goal was evaluating the incidence of adverse events in 42 follow-up period.
The secondary outcome of this study is determining fever clearance rate based on fever clearance time. 42 days 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).
The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period. 42 days 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.
The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time. 42 days 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.
The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time. 42 days 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.
Trial Locations
- Locations (1)
Shecha Health Center
🇪🇹Arba Minch, South Ethiopia, Ethiopia