Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-01 @ 2:21 AM
Study NCT ID:
NCT06806956
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-04
First Post:
2024-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Malaria in Remote Areas- Closing the Evidence Gap
Sponsor:
Tropical Diseases Research Centre, Zambia
Organization:
Study Overview
Official Title:
Severe Malaria Treatment With Rectal Artesunate and Artemisinin-based Combination Therapy in Remote Settings
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEMA ReACT
Brief 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 clinical outcomes of rectal artesunate plus Artemisinin based Combination Therapy for patients 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.
* 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
* To evaluate the clinical outcomes of rectal artesunate plus Artemisinin based Combination Therapy for patients 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.
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 101103191 | OTHER_GRANT | HORIZON-JU-GH-EDCTP3-2022-CALL1-01-01 | View |