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Severe Malaria in Remote Areas- Closing the Evidence Gap

NCT06806956 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 2016

Last updated 2026-01-27

No results posted yet for this study

Summary

The goal of this observational study is to assess whether the giving of rectal artesunate and a three day course of an Artemisinin based Combination Therapy (ACT) to children aged 6 months and ≤ 5 years with severe malaria when referral is not feasible is non inferior to giving of injectable artesunate and three day course of an ACT. The three primary objectives are:

* To evaluate the 28-day PCR corrected cure rate in children aged 6 months to ≤ 5 years treated with RAS+ACT or RAS+injectable artesunate, assessing whether each treatment achieves the clinically acceptable cure rate of 97% ± 5%.
* To evaluate feasibility of provision of rapid treatment of severe malaria with rectal artesunate in children 6 months to ≤ 5 years not able to access a referral health facility, by a community health worker or in health facility where there is no injectable artesunate available.
* To evaluate the impact of reinforcing the integrated Community Case Management (iCCM) on access to the formal health care system

The study is being done in Nchelenge district in Zambia and Kapolowe district in the Democratic Republic of Congo. It will enrol 1008 children with severe malaria and an equal number of children with simple malaria

Conditions

  • Severe Malaria

Interventions

DRUG

Treatment of severe malaria with either RAS + ACT or RAS + injectable artesunate + ACT will each achieve the clinically acceptable cure rate of 97% ± 5% in remote areas

The Community Health Worker will give rectal artesunate (RAS) +artemisinin based combination Therapy (ACT) to children aged 6 months to less than or equal to 5 years who fail to make the referral trip. Those who make the referral trip will receive injectable artesunate and artemisinin based Combination Therapy for three days. Giving of RAS +ACT is unique to this study. Children with non malaria severe disease will also receive amoxicillin from the community health worker before they are referred to the next level of care

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • University of Kinshasa

    collaborator OTHER

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Medicines for Malaria Venture

    collaborator OTHER

  • Université de Lubumbashi

    collaborator OTHER

  • Tropical Diseases Research Centre, Zambia

    lead OTHER_GOV

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-10
Primary Completion
2027-03-31
Completion
2027-04-30

Countries

  • Democratic Republic of the Congo
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06806956 on ClinicalTrials.gov