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IV ARTESUNATE PLUS ACT Vs IV QUININE PLUS ACT AND EVALUATION OF PHARMACOKINETICS OF ARTEMETHER-LUMEFANTRINE AND DIHYDROARTEMISININ-PIPERAQUINE

INTRAVENOUS ARTESUNATE PLUS ACT Vs INTRAVENOUS QUININE PLUS ACT FOR SEVERE MALARIA TREATMENT IN UGANDAN PATIENTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201110000321348
Enrollment
404
Registered
2011-10-04
Start date
2011-10-24
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

Intravenous quinine plus ACT
IV artesunate plus ACT

Sponsors

INFECTIOUS DISEASES INSTITUTE LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age 6 months and above 2) With a positive blood smear for P. falciparum asexual parasitaemia with no other cause of the symptoms 3) Who meet the WHO clinical or laboratory criteria for severe malaria requiring parenteral therapy 3) Whose parents/caretakers provide written informed consent and are willing to participate in 42 day follow up

Exclusion criteria

Exclusion criteria: 1) Administration of any additional antimalarial drugs that are not study drugs within 72 hours before study enrolment and during the course of the study. 2) Emergence of any non-malarial febrile illness which may interfere with the classification of malaria treatment outcome 3) Movement away from the study area interfering with follow-up assessment 4) Patients with contraindications to taking the study drugs 5) Withdrawal of consent

Design outcomes

Primary

MeasureTime frame
Treatment failure unadjusted by genotyping

Secondary

MeasureTime frame
Treatment failure adjusted by genotyping;Time to event outcomes including: fever and parasite clearance times, coma recovery time, time to begin oral intake and time to sit up unsupported;Haemoglobin recovery on day 28;Adverse events

Countries

Uganda

Contacts

Public ContactMOHAMMED LAMORDE

CO-INVESTIGATOR

mlamorde@idi.co.ug+256 772 185590

Outcome results

None listed

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