Triple combination therapy to delay malaria drug resistance
Can Triple Artemisinin-based Combination Therapy for Treatment of Uncomplicated Plasmodium Falciparum Malaria, Delay Drug Resistance Development of Plasmodium Falciparum in Tanzania: a Randomized Three Arm Clinical Trial
This study is testing a new way to treat malaria in children by using a combination of three different medications to see if it works better and helps prevent the parasites from becoming resistant to the drugs.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Ages | 6 Months to 120 Months |
| Sex | All |
| Sponsor | Muhimbili University of Health and Allied Sciences Academic / other |
| Locations | 2 sites (Bagamoyo, Dar esSalaam and 1 other locations) |
| Trial ID | NCT05764746 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a sequential administration of triple artemisinin-based combination therapies (ACTs) to treat uncomplicated Plasmodium falciparum malaria. It involves a three-arm partially blinded randomized design comparing two different combinations of ACTs against a placebo. The study aims to improve treatment efficacy and delay the development of drug resistance in malaria parasites. Eligible participants include children aged 6 to 120 months with confirmed uncomplicated malaria.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 120 months with microscopy confirmed uncomplicated P. falciparum malaria.
Not a fit: Patients with severe malaria, known allergies to trial medications, or those under 6 months of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of malaria treatment and prolong the efficacy of existing therapies.
How similar studies have performed: Other studies have shown promise in using combination therapies to combat drug resistance in malaria, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients presenting at the health facility with suspected acute uncomplicated malaria will be screened for eligibility. Inclusion Criteria: * Age from 6 - 120 months * Weight ≥ 5 kg * Body temperature ≥37.5°C or history of fever in the last 24 hours * Microscopy confirmed P. falciparum mono-infection * Parasitemia level of 1000-200000/μL * Ability to swallow oral medication * Ability and willingness to abide by the study protocol and the stipulated follow-up visits * A written proxy informed consent from a parent/guardian Exclusion Criteria: * Children aged below 6 months will not be included in the study because ACTs are contraindicated in this group. * Evidence of severe malaria or danger signs * Known allergy to trial medicines * Reported antimalarial intake ≤2 weeks * Haemoglobin \<5 g/dL * Blood transfusion within last 90 days * Febrile condition other than malaria * Known underlying chronic or severe disease (including severe malnutrition).
Where this trial is running
Bagamoyo, Dar esSalaam and 1 other locations
- Kibindu — Bagamoyo, Dar esSalaam, Tanzania (Recruiting)
- Yombo Dispensary — Bagamoyo, Yombo, Tanzania (Suspended)
Study contacts
- Principal investigator: Billy E Ngasala, PhD — Muhimbili University of Health and Allied Sciences
- Study coordinator: Lwidiko E Mhamilawa, PhD
- Email: lwidikoedward@gmail.com
- Phone: +255712865206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.