Status:
COMPLETED
Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax
Lead Sponsor:
Dinka Dugassa
Collaborating Sponsors:
Ethiopian Public Health Institute
Conditions:
Efficacy
Malaria
Eligibility:
All Genders
6+ years
Phase:
PHASE4
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 E...
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 E...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06044805
Start Date
December 19 2022
End Date
March 15 2023
Last Update
September 22 2023
Active Locations (1)
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1
Shecha Health Center
Arba Minch, South Ethiopia, Ethiopia