Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax (CQ+PQ)

Dinka Dugassa

Status and phase: Completed; Phase 4

Conditions: Vivax Malaria; Chloroquine; Efficacy; Malaria

Treatments: Drug: Primaquine; Drug: Chloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT06044805

EPHI-IRB-294-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Therapeutic Efficacy of Chloroquine Plus Primaquine

Experimental group

Description:

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.

Treatment:

Drug: Primaquine

Drug: Chloroquine