Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201309000625311 Date of Approval: 22/08/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for Plasmodium falciparum infection
Official scientific title Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for Plasmodium falciparum infection
Brief summary describing the background and objectives of the trial The trial aims at finding the ideal antimalarial drug that may be used in various malaria vaccine trials to clear parasites before assessing if one is acquiring new infections after vaccinations.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MalPaC
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/10/2013
Actual trial start date
Anticipated date of last follow up 28/02/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
1034-13 OxTREC
SSC 2565 KEMRI Scientific Steering Committee
ECCT/13/08/02 Pharmacy and Poison's Board Kenya
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation into the study groups will be done by an independent statistician using STATA and the study clinicians with an allocation ratio of 1:1:1 to study groups Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artesunate 400 mg loading dose (day 1) and 200mg once daily for 6 days 7 days Group 2 30
Experimental Group Atovaquone proguanil plus Artesunate 4 tablets each of (250/100 mg atovaquone/proguanil + 200 mg artesunate) once daily 3 days Group 1 30
Experimental Group Sulfadoxine/Pyrimethamine + Artesunate + Primaquine 3 tablets of 500/25 mg sulfadoxine/pyrimethamine one dose on day 1 + 200 mg artesunate once daily for 3 days + 15mg primaquine one dose on day 1 1 dose S/P on day 1 + 3 days artesunate + 1 dose primaquine on day 1 Group 3 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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). 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/07/2013 KEMRI Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road Nairobi PO Box 54840-00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/08/2013 OxTREC
Ethics Committee Address
Street address City Postal code Country
Joint Research Office block 60, Churchill hospital Oxford OX3 7LE Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to first episode of P.falciparum infection Day 7, 9, 10, 14, 16, 17, 21, 23, 24, 28, 30, 35, 37, 42, 44, 48, 56, 63, 70, 77, 84
Secondary Outcome We will determine the percentage of PCR results that are confirmed by RNA positive results indicating live P. falciparum parasites. Day 1, 2, 4, 7, 9, 10, 14, 16, 17, 21, 23, 24, 28, 30, 35, 37, 42, 44, 48, 56, 63, 70, 77, 84 only if low level parasitaemia is present at these time-points
Secondary Outcome 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. Day 7, 9, 10, 14, 16, 17, 21, 23, 24, 28, 30, 35, 37, 42, 44, 48, 56, 63, 70, 77, 84
Secondary Outcome 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. Day 7
Secondary Outcome 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. Day 0, 1, 2, 4, 7, 9, 10, 14, 16, 17, 21, 23, 24, 28, 30, 35, 37, 42, 44, 48, 56, 63, 70, 77, 84
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Junju Dispensary 96 Vipingo Kilifi 96 Vipingo Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KEMRI Wellcome Trust Research Programme Hospital Grounds, off Bofa Road Kilifi PO Box 230-80108 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
University of Oxford, CCVTM Churchill Hospital Old Road, Headington Oxford OX3 7LJ United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caroline Ogwang cogwang@kemri-wellcome.org +254 41 7522 063 Hospital grounds off Bofa Road
City Postal code Country Position/Affiliation
Kilifi PO Box 203-80108 Kenya KEMRI Wellcome Trust Research Programme
Role Name Email Phone Street address
Public Enquiries Judy Peshu jpeshu@kemri-wellcome.org +254 41 7522 063 Hospital grounds off Bofa Road
City Postal code Country Position/Affiliation
Kilifi PO Box 230-80108 Kenya KEMRI Wellcome Trust Research Programme
Role Name Email Phone Street address
Scientific Enquiries Philip Bejon pbejon@kemri-wellcome.org +254 41 7522 063 Hospital grounds off Bofa Road
City Postal code Country Position/Affiliation
Kilifi PO Box 230-80108 Kenya KEMRI Wellcome Trust Research Programme/University of Oxford
Role Name Email Phone Street address
Scientific Enquiries Francis Ndungu fndungu@kemri-wellcome.org +254 41 7522 063 Hospital grounds off Bofa Road
City Postal code Country Position/Affiliation
Kilifi PO Box 230-80108 Kenya KEMRI Wellcome Trust Research Programme
REPORTING
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