A phase III, randomised, non-inferiority trial, to assess the efficacy and safety of dihydroartemisinin and piperaquine (DHA + PPQ, Artekin®) in comparison with artesunate and mefloquine (AS + MQ) in patients affected by acute, uncomplicated Plasmodium falciparum malaria

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN81306618
• Lead Sponsor: Sigma-Tau (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

1. Males and females aged between three months and 65 years inclusive
2. Body weight at least 5 kg
3. Microscopically confirmed, monoinfection of Plasmodium falciparum or mixed infection
4. History of fever or presence of fever (tympanic temperature at more than or equal to 37.5°C)
5. Written informed consent
6. 1050 patients (700 DHA + PPQ; 350 AS + MQ)

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Day 63, PCR corrected cure rates of artekin and AS+MQ

Secondary Outcome Measures

Name	Time	Method
1. The comparison of the uncorrected Day 63 cure rates of both drugs (also known as adequate clinical and parasitological response [ACPR]) <br>2. The comparison of the amount of overall treatment failure <br>3. The comparison of the safety profiles of the two treatments<br>4. Proportion of patients with treatment failure (TF)<br>5. Proportion of aparasitaemic patients<br>6. Proportion of afebrile patients<br>7. Gametocytes carriage<br>8. Fractional change in haemoglobin/haematocrit