Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for Plasmodium falciparum infectio

Not Applicable

• Conditions: Malaria

• Registration Number: PACTR201309000625311
• Lead Sponsor: KEMRI Wellcome Trust Research Programme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Consenting adults aged 18 ¿ 50 years in good health.
Will remain resident in the study area for the study duration.
Able and willing (in the Investigator¿s opinion) to comply with all study requirements
Informed Consent

Exclusion Criteria

Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Haemoglobin less than 11.3 g/dl for men and less than 10g/dl for in women, where judged to be clinically significant in the opinion of the investigator.
Blood transfusion within the month preceding enrolment.
Current participation in another clinical trial or recent participation within 12 weeks of this study.
Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
Pregnant or lactating women.
Women unwilling to use contraception for the duration of drug treatment.
Likelihood of travel away from the study area

Withdrawal criteria
By withdrawing consent
On the decision of the investigator
The investigator may withdraw the subject for the following reasons:
Any adverse event which results in the inability to comply with study procedures
Ineligibility either arising during the study or retrospectively
Significant protocol deviation.
Loss to follow up (applies to a subject who consistently does not return for protocol study visits, is not reachable by telephone or any other means of communication and/ is not able to be located).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first episode of P.falciparum infection

Secondary Outcome Measures

Name	Time	Method
We will determine the percentage of PCR results that are confirmed by RNA positive results indicating live P. falciparum parasites.;We will compare the percentage of positive results on day 7 following the start of the drug regimen to examine clearance rates. We will examine the longitudinal patterns of PCR positivity to distinguish re-infection from failure to clear parasites.;We will collect data on tolerability of drugs when participants attend on day 7. We will ask specifically regarding headache, itching, visual disturbances, general weakness, anorexia, nausea and vomiting, abdominal pain, and diarrhoea, and will collect other spontaneously reported adverse events.;We will determine how much exposure to malaria might be missed by relying on PCR measurements, by examining serological responses to malaria antigens at baseline, during the study, and at the end of the study.