An observational study in Severe Malaria, sponsored by Tropical Diseases Research Centre, Zambia. Enrolling by invitation at 2 sites in 2 countries. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Tropical Diseases Research Centre, Zambia · Observational
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:
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
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 2,016 is above the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →Tropical Diseases Research Centre, Zambia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will comprise children 6 months to ≤5 years of age living in Kapolowe, DRC and those living in Nchelenge, Zambia who present with a suspected diagnosis of severe malaria or uncomplicated malaria, confirmed by a rapid diagnostic test; or non-malaria severe disease
Inclusion Criteria:
Inclusion criteria for severe malaria
Children aged from 6 months to ≤5 years that present at the health system and are either; with fever (or history of fever within 2 days) and have a positive mRDT test plus at least one of the following danger signs for malaria (as per standardized national iCCM guidelines):
Inclusion for severe non-malaria
Children aged from 6 months to ≤5 years that present at the health system and are either; with fever (or history of fever within 2 days) and have a negative mRDT test plus at least one of the following danger signs as per standardized national iCCM guidelines:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group of interest is children aged between 6 months and less than or equal to 5 years with severe malaria. However, we will also enrol children of the same age group with simple malaria and non malaria severe disease to compare their journeys as well
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
The time from onset of symptoms to initiating treatment
The time from onset of symptoms to initiating treatment among children 6 months to ≤5 years with severe malaria and/or not able to take oral treatment that seek health care from the CHW or other HF system as primary first contact
Time frame: The time from onset of symptoms to initiating treatment
PCR-corrected cure rate at 28 days from enrollment in patients aged 6 months to ≤5 years.
PCR-corrected cure rate at 28 Days from enrollment in patients aged 6 months to ≤5 years in areas where referral for follow-up treatment with injectable artesunate is not feasible, compared to outcomes obtained after full referral is completed
Time frame: 28 Days from enrollment
Change from baseline proportion of sick children 6 months - ≤5 years at population level that went to the formal health system during the last 6 months including suspected (severe) malaria at month 20 (phase 4).
Two cross section surveys one at month 1 (baseline) and the other at month 20 (phase 4) will be used to obtain the proportion of sick children 6 months to ≤5 years at population level that were either attended by a Community Health Worker, Health post or Health Centre in the last 6 months
Time frame: At month 20 (phase 4)
Plan to share: No — We will only share aggregated data as IPD will not be useful to the research community
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 36 months after the start.
Of 85 non-industry observational studies under Malaria, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 36. This study's planned 36 months is above that.
Counting every sponsor, half of 93 studies reached it within 24 months; a quarter within 16 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Tropical Diseases Research Centre, Zambia