By InvitationNot Applicable

Severe Malaria in Remote Areas- Closing the Evidence Gap

Democratic Republic of the Congo, Zambia2,016 participantsStarted 2024-03-10

Plain-language 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

Who can participate

Age range6 Months – 5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion criteria for severe malaria * From a village without other research interventions * 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): * convulsions * inability to drink, eat, or suck * vomiting all liquids and solids * altered consciousness/coma * lethargy * chest in-drawing Inclusion for uncomplicated malaria * Children aged from 6 months to ≤5 years; with fever (or history of fever within 2 days) with no danger signs for malaria (as per the standardized national Integrated Management of Childhood Illnesses guidelines) with a positive mRDT for Plasmodium falciparum histidine-rich protein. Inclusion for severe non-malaria * From a village without other research interventions * 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: * convulsions * inability to drink, eat, or suck * vomiting all liquids and solids * altered consciousness/coma * lethargy * chest in-drawing * For participants in sentinel sites, a written informed consent will be provided by the patient's parent or guardian to take …

What they're measuring

The time from onset of symptoms to initiating treatment

Timeframe: 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.

Timeframe: 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).

Timeframe: At month 20 (phase 4)

Trial details

NCT IDNCT06806956

SponsorTropical Diseases Research Centre, Zambia

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2027-03

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