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

EPHI-IRB-294-2

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.

2022-12-19

2023-03-13

2023-03-15

Completed

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label clinical trial study will be conducted in Shecha Health Center from December 2022 to March 2023. Participants will be selected and treated with a 25 mg/kg standard dose of chloroquine over three days and a 0.25 mg/kg standard dose of primaquine over fourteen days. Clinical, parasitologic, and hematologic parameters will be monitored for up to a 42-day follow-up period, which will be used to evaluate therapeutic efficacy of CQ+PQ. Thick and thin blood smears will be prepared and examined to determine parasite clearance, and clinical examination will be performed over 42 follow up periods. Haemoglobin level will be measured on days 0, 14, 28 and 42. WHO double-entry Excel sheet will be used for KaplanMeier survival analysis and SPSS version-26 software will be used to analyse the data. All comparisons will be performed at 95% confidence interval and a significance level of 0.05, Pvalue of \\<0.05 will be considered statistically significant', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-09-22