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.: PACTR201303000506302 Date of Approval: 22/02/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Antimalarial Dose Justification and Tolerability Study of DHA-Piperaquine in the 5-24 kg Weight Band in Malawi
Official scientific title Antimalarial Dose Justification and Tolerability Study of DHA-Piperaquine in the 5-24 kg Weight Band in Malawi
Brief summary describing the background and objectives of the trial Previous studies suggest that the current recommended therapeutic weight-adjusted dose of piperaquine is too low for young children because they have a higher body weight-normalised oral clearance. The purpose of this study is to assess the population pharmacokinetic profile and tolerability of an increased and more pragmatic regimen of dihydroartemisinin-piperaquine in children with uncomplicated falciparum malaria in the 5-24 kg weight band.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ADJusT
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2014
Actual trial start date 21/01/2014
Anticipated date of last follow up 31/07/2014
Actual Last follow-up date 02/12/2015
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 106
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
#1142 National Health Sciences Research Committee (NHSRC), Malawi
13.13 Liverpool School of Tropical Medicine (LSTM), United Kingdom
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
Non-randomised Open-label(Masking Not Used)
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dihydroartemisinin-piperaquine once daily according to body weight 3 days 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
* Children with uncomplicated falciparum malaria confirmed by rapid diagnostic test (RDT) * Axillary temperature ¿ 37.5 °C * Parasite density 2,000-200,000/microliter * Body weight 5.0-24.9 kg * Provision of informed consent by parent or guardian * Intention to return for directly observed treatment and follow-up visits * Hypersensitivity to the study drug * Signs of severe malaria at screening * Family history of sudden death or of congenital prolongation of the QTc interval * Baseline QTc-interval > 450msec * Known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval * History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia * Any history of cardiac disease, including congenital heart disease or rheumatic heart disease, uncontrolled hypertension, hypertrophic cardiomyopathy, any underlying cardiomyopthy with reduced left ventricular ejection fraction * Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia * Taking medicinal products that are known to prolong the QTc interval * Known renal or hepatic insufficiency * Severe malnutrition * Severe anaemia (haemoglobin <5g/dl) * Mental impairment * Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products * Intent to reside outside of catchment area during the course of the study or likely to be non-compliant with the follow-up schedule, i.e. recent arrivals or known mobile populations 0 Year(s) 999 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 19/02/2013 Liverpool School of Tropical Medicine (LSTM) Research Ethics Committee (REC)
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom
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 National Health Sciences Research Committee (NHSRC), Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Lilongwe 3 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy: Blood sample for multiple dose pharmacokinetic profile * Day 0: before treatment (baseline) * Day 0: 0-6 h after first dose (absorption) * Day 1: 0-6 h after second dose * Day 2: 0-6 h after third dose (Cmax) * Day 3: during follow-up * Day 7: during follow-up (Day 7) * Day 28, 42 or 63: during follow-up (tail)
Primary Outcome Efficacy: Malaria blood smear and filter paper samples At every scheduled (Days 0, 1, 2, 3, 7, 28, 42 and 63) and unscheduled visit
Primary Outcome Safety: Electrocardiogram * Day 0: before treatment (baseline) * Day 2: before and 4-6 h after third dose (Cmax) * Day 28
Primary Outcome Safety: Haemoglobin At every scheduled (Days 0, 1, 2, 3, 7, 28, 42 and 63) and unscheduled visit
Primary Outcome Safety: Adverse events At every scheduled (Days 0, 1, 2, 3, 7, 28, 42 and 63) and unscheduled visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chikhwawa District Hospital (CDH) Chikhwawa Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trial Partnership (EDCTP) Laan van Nieuw Oost Indië 334 The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine (LSTM) Pembroke Place Liverpool L3 5QA United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
College of Medicine Private Bag 360, Chichiri Blantyre 3 Malawi
University of Cape Town, Faculty of Health Sciences Private Bag, Observatory Cape Town 7935 South Africa
Malawi-Liverpool-Wellcome Trust Clinical Research Programme (MLW) P.O. Box 30096, Chichiri Blantyre 3 Malawi
Liverpool School of Tropical Medicine (LSTM) Pembroke Place Liverpool L3 5QA United Kingdom
Mahidol-Oxford Tropical Medicine Research Unit (MORU) 420/6 Ratchawithi Road Bangkok 10400 Thailand
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dianne J. Terlouw Anja.Terlouw@LSTMed.ac.uk +265 (0)1 871 911
City Postal code Country Position/Affiliation
Blantyre Malawi Malawi-Liverpool-Wellcome Trust Clinical Research Programme / College of Medicine
Role Name Email Phone Street address
Public Enquiries Dianne J. Terlouw Anja.Terlouw@LSTMed.ac.uk +265 (0)1 871 911
City Postal code Country Position/Affiliation
Blantyre Malawi Malawi-Liverpool-Wellcome Trust Clinical Research Programme / College of Medicine
Role Name Email Phone Street address
Scientific Enquiries Dianne J. Terlouw Anja.Terlouw@LSTMed.ac.uk +265 (0)1 871 911
City Postal code Country Position/Affiliation
Blantyre Malawi Malawi-Liverpool-Wellcome Trust Clinical Research Programme / College of Medicine
REPORTING
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Result URL Hyperlinks
Changes to trial information