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

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201110000321348
• Date of registration: 04/10/2011
• Primary sponsor: INFECTIOUS DISEASES INSTITUTE LTD
• Public title: IV ARTESUNATE PLUS ACT Vs IV QUININE PLUS ACT AND EVALUATION OF PHARMACOKINETICS OF ARTEMETHER-LUMEFANTRINE AND DIHYDROARTEMISININ-PIPERAQUINE
• Scientific title: INTRAVENOUS ARTESUNATE PLUS ACT Vs INTRAVENOUS QUININE PLUS ACT FOR SEVERE MALARIA TREATMENT IN UGANDAN PATIENTS
• Date of first enrolment: 2012-01-02
• Target sample size: 404
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000321348
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation using a randomisation table created by a computer software program,; sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: JANE ACHAN
• Affiliation: Co-PI

• Name: MOHAMMED LAMORDE
• Affiliation: CO-INVESTIGATOR

Key inclusion & exclusion 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: 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


Age minimum: 6 Month
Age maximum: 60 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

Treatment failure unadjusted by genotyping

Secondary Outcome(s)

Adverse events

Haemoglobin recovery on day 28

Time to event outcomes including: fever and parasite clearance times, coma recovery time, time to begin oral intake and time to sit up unsupported

Treatment failure adjusted by genotyping

Secondary ID(s)

HS 1031

REC REF 2011-175

Source(s) of Monetary Support

EDCTP