Assessing the spread of artemisinin-resistant malaria parasites before and after treatment
The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy: a Longitudinal Study
PHASE4 · Infectious Diseases Research Collaboration, Uganda · NCT06347471
This study is testing how artemisinin-resistant malaria parasites spread in people with malaria before and after they receive standard treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Infectious Diseases Research Collaboration, Uganda (other) |
| Locations | 2 sites (Kalongo, Agago district and 1 other locations) |
| Trial ID | NCT06347471 on ClinicalTrials.gov |
What this trial studies
This study investigates the transmission dynamics of artemisinin-resistant malaria parasites in a region where such resistance has emerged. Participants with uncomplicated malaria and asymptomatic infections will be treated with standard artemisinin-combination therapies. The study will assess the transmission potential of both resistant and wild-type infections using various methods, including microscopy and mosquito feeding assays. The goal is to understand how these resistant parasites spread before and after treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 years and older who are diagnosed with uncomplicated P. falciparum malaria and are positive for gametocytes.
Not a fit: Patients with severe malnutrition or other febrile conditions unrelated to malaria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing and controlling malaria transmission in the context of drug resistance.
How similar studies have performed: Other studies have shown success in understanding malaria transmission dynamics, but the specific focus on artemisinin resistance in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥2 years * blood smear positive for P. falciparum gametocytes * mono-infection with P. falciparum confirmed by positive blood smear; * parasitaemia of \>100 P. falciparum asexual forms/µL; * ability to swallow oral medication; * ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; * informed consent from parent or guardian; * haemoglobin ≥ 7.0 g/dl for children below 10 years of age or ≥8.0g/dL for older individuals Exclusion Criteria: * presence of general danger signs; * mixed or mono-infection with another Plasmodium species detected by microscopy; * presence of severe malnutrition defined as a very low weight for height (below -3z scores of the median WHO growth standards), by visible severe wasting, or by the presence of nutritional oedema. * presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); * history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested
Where this trial is running
Kalongo, Agago district and 1 other locations
- Dr. Ambrosoli Memorial Hospital — Kalongo, Agago district, Uganda (RECRUITING)
- Patongo Health Facility IV — Patongo, Agago district, Uganda (RECRUITING)
Study contacts
- Principal investigator: Teun Bousema, PhD — London School of Hygiene and Tropical Medicine
- Study coordinator: Emmanuel Arinaitwe, PhD
- Email: earinaitwe@idrc-uganda.org
- Phone: +256 752900078
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.
Conditions: Falciparum, Malaria, Malaria Transmission, Artemisinin resistance, Gametocytes, Spread of resistance