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An open label, randomised comparative study of supervised and unsupervised amodiaquine plus artesunate treatment for acute uncomplicated Plasmodium falciparum malaria in the Kassena Nankana District of Ghana

An open label, randomised comparative study of supervised and unsupervised amodiaquine plus artesunate treatment for acute uncomplicated Plasmodium falciparum malaria in the Kassena Nankana District of Ghana

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74716448
Enrollment
350
Registered
2008-02-29
Start date
2005-11-01
Completion date
Unknown
Last updated
2019-06-26

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

Conditions

Acute malaria Infections and Infestations malaria

Interventions

Supervised group: Each administration of artesuante and amaodiaquine will be supervised by a health professional Unsupervised group: The participants will receive the first dose as abo

Sponsors

Ghana Health Service (Ghana)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Signed witnessed informed consent 2. Bodyweight >5 kg 3. P. falciparum mono-infection with parasite density of 2,000-200,000 asexual parasites per microlitre 4. Fever (axillary temperature greater than or equal to 37.5 C) and/or history of fever 5. Haemoglobin >6.0 g/dl

Exclusion criteria

Exclusion criteria: 1. Danger signs of severe malaria 2. Severe malnutrition 3. History of allergy to drugs 4. Other underlying chronic diseases

Design outcomes

Primary

MeasureTime frame
Adequate clinical and parasite clearance. Timepoints of measurement: Days 2, 3, 7, 14, 21 and 28

Secondary

MeasureTime frame
Parasite and fever clearance times. Timepoints of measurement: Days 2, 3, 7, 14, 21 and 28

Countries

Ghana

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026