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Efficacy of dual parenteral artemisinin-based combination therapy for cerebral malaria in a randomized control trial in Nigerian children.

Efficacy of dual parenteral artemisinin-based combination therapy for cerebral malaria in a Tripple blind randomized control trial in Nigerian children.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202102893629864
Enrollment
359
Registered
2021-02-23
Start date
2021-07-21
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Parenteral dual artemisinin based antimalarial artesunate and quinine
Monotherapy with either quinine alone or artesunate alone

Sponsors

Alao Michael and Co Authors
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Children between the ages of 6 months to 17 years as at the last birthday 2.Children with unarousable coma lasting more than 30 minutes in the presence of demonstratable peripheral asexual P. falciparum parasitemia. 3.Children who develop deterioration in their level of consciousness after admission and demonstrate asexual Plasmodium falciparum in the peripheral blood.

Exclusion criteria

Exclusion criteria: 1.Children with positive biochemical and/or microbiological CSF result consistent with a diagnosis of meningitis 2.Children who have intracranial infections or intracranial space-occupying lesions 3.Children with previous neurological deficit either focal or global

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the effectiveness of dual parenteral antimalaria in the treatment of cerebral malaria compared to the standard of care in terms of survival and full recovery in tertiary hospitals in Nigeria.

Secondary

MeasureTime frame
The secondary outcomes include the parasite clearance rate, fever defervescence, time to recovery of consciousness, and the side effect profile of interventions (treatment and control arms).

Countries

Nigeria

Contacts

Public ContactAbayomi Oyenuga

Clinician Biostatistician

oaoyenuga@gmail.com+16513996981

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026