Severe Malaria in Remote Areas- Closing the Evidence Gap

Официальное название

Severe Malaria Treatment With Rectal Artesunate and Artemisinin-based Combination Therapy in Remote Settings

Обзор

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

Вмешательства

• Препарат 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

Первичные конечные точки

• The time from onset of symptoms to initiating treatment [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: At month 20 (phase 4)]

Критерии участия

Критерии включения

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 filter paper blood samples and to participate in interviews (questionnaires and IDI) at enrolment, day 14 and day 28 (to assess malaria recurrence and look for markers of resistance). If the parent or guardian is unable to write, thumb print witnessed consent is permitted. The informed consent shall be administered by the CHWs. Willingness and ability of the patient and the parent or guardian to comply with the treatment policy.

Критерии исключения

• Use of any investigational or non-registered product or planned use during the study period.
• Participation in other studies within 30 days before the current study begins and/or during study participation.
• Inability to comprehend and/or unwillingness to follow the study protocol.
• For RAS use: if the child has reacted badly to artesunate in the past (in sites where RAS is administered)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Democratic Republic of the Congo · 1 центр

• University of Kinshasa — Kinshasa

Zambia · 1 центр

• Tropical Diseases Research Centre — Ndola

Идентификаторы

NCT: NCT06806956 · Version 2.0 Dated 5 March 2024 · 101103191

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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