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Uganda Malaria Surveillance Project - Combination therapies for treatment of uncomplicated falciparum malaria in Uganda: evaluation of efficacy, safety, and tolerability

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67520427
Enrollment
2160
Registered
2005-05-10
Start date
2002-11-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Malaria Infections and Infestations Malaria

Interventions

Chloroquine + sulfadoxine-pyrimethamine versus amodiaquine + sulfadoxine-pyrimethamine versuss amodiaquine + artesunate

Sponsors

Uganda Malaria Surveillance Project (Uganda)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged over six months 2. Fever (more than 37.5 ºC axillary) or history of fever in the previous 24 hours 3. Absence of any history of serious side effects to study medications, including allergy to sulfa drugs 4. No evidence of severe malaria or danger signs 5. No evidence of a concomitant febrile illness 6. P. falciparum mono-infection 7. Parasite density more than 2000/ul and less than 200,000/ul 8. Agreement to return for all scheduled follow-up visits 9. Provision of informed consent 10. No history of anti-folate or amodiaquine use in past seven days 11. Absence of pregnancy

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
1. 28-day risks for any recurrent infection 2. Recrudescence 3. New infections.

Secondary

MeasureTime frame
1. Risk of recurrent infection unadjusted by genotyping at day 14 2. Presence of fever on days one to three 3. Parasitemia on days two and three 4. Change in haemoglobin level between the day of enrolment and the last day of follow-up 5. Presence of gametocytes during any follow-up day 6. Incidence of adverse events

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 13, 2026