A randomised, open label, controlled trial to assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of primary and the prevention of secondary infections with Plasmodium falciparum

Completed

Conditions: ncomplicated Plasmodium falciparum malaria
Plasmodium falciparum malaria
Infections and Infestations

Registration Number: ISRCTN88705995

Lead Sponsor: niversity of Heidelberg School of Medicine (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Males and females aged between 6 months and 59 months inclusive
2. Body weight of 5 kg and above
3. Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia greater than or equal to 2,000/µL to 200,000/µL)
4. History of fever in the previous 24 hours or presence of fever (axillary temperature at greater than or equal to 37.5°C)
5. Signed informed consent by the parents or guardians
6. Parents? or guardians? willingness and ability to comply with the study protocol for the duration of the trial

Exclusion Criteria

1. Participation in any investigational drug study during the previous 30 days
2. Known hypersensitivity to the study drugs
3. Severe malaria
4. Danger signs: not able to drink or breast-feed, vomiting (greater than twice in 24 hours), recent history of convulsions (greater than one in 24 hours), unconscious state, unable to sit or stand
5. Electrocardiogram (ECG) abnormality that requires urgent management
6. Presence of intercurrent illness or any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study
7. Severe malnutrition (defined as weight for height less than 70% of the median National Center for Health Statistics [NCHS]/World Health Organisation [WHO] reference)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The cure ratio of dihydroartemisinin-piperaquine is non-inferior to that of artemether-lumefantrine (non-inferiority margin = 5%)<br>2. The cure ratio of dihydroartemisinin-piperaquine is at least 90%

Secondary Outcome Measures

Name	Time	Method
1. Polymerase chain reaction (PCR)-uncorrected day 28 cure ratio<br>2. Safety profiles of the two treatments<br>3. Time to asexual parasite clearance (PCT)<br>4. Time to fever clearance (FCT)<br>5. Gametocyte prevalence and density on days 7, 14, 28, 42, 63 and 84<br>6. Haematological recovery (Haemoglobin [Hb] changes) from day 0 to day 28, day 42, and day 84<br>7. Cure ratios at day 42 (PCR corrected and PCR uncorrected)<br>8. Cure ratios at day 63 (PCR corrected and PCR uncorrected)<br>9. Cure ratios at day 84 (PCR corrected and PCR uncorrected)<br>10. Rate of PCR-confirmed reinfections to estimate the chemoprophylactic effect of dihydroartemisinin-piperaquine