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.: PACTR201302000476155 Date of Approval: 17/12/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
Official scientific title An Open-label, Single-arm Study to Evaluate the Efficacy, Safety and PK of Artemether-lumefantrine Dispersible Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants <5 kg Body Weight
Brief summary describing the background and objectives of the trial The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Other
Anticipated trial start date 08/10/2012
Actual trial start date 08/10/2012
Anticipated date of last follow up 08/07/2014
Actual Last follow-up date 08/07/2014
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL http://www.malariajournal.com/content/14/1/157
Secondary Ids Issuing authority/Trial register
2011-005858-33 EUDRACT
NCT01619878 ClinicalTrials.gov
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)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group artemether-lumefantrine 20 mg/120 mg dispersible tablet 1 dispersible tablet bid 3 days Infants aged >28 days 20
Experimental Group artemether-lumefantrine 20 mg/120 mg dispersible tablet 1 dispersible tablet bid 3 days Neonates of a term age 0 to 28 days 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Neonates or infants 2. Body weight less than 5kg 3. In cohort 1 infants older than 28 days In cohort 2 neonates of term age 0 to 28daysincl 4. Microscopically confirmed diagnosis of acure uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmofium falciparum parasitaemis off more than 1000 and les thatn 100 000 parasites per µL 1. Presence of severe malaria (according to World Health Organization definition) 2. Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants) 3. Presence of any clinically significant neurological condition 4. Presence of clinically significant abnormality of the hepatic and renal systems 5. Patients who sustained a significant blood volume loss (> 3% of calculated blood volume) in the past 30 days 6. Patients unable to swallow or whose drinking is impaired 7. Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease 8. Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia) 9. Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities 10. Other protocol-defined inclusion/exclusion criteria may apply. 0 Day(s) 1 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 17/05/2012 Ethics Committee Basle (EKBB)
Ethics Committee Address
Street address City Postal code Country
Hebelstrasse 53 Basle 4056 Switzerland
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 06/06/2012 Comité d'Ethique pour la recherche en Santé
Ethics Committee Address
Street address City Postal code Country
09 BP 668 Ouagadougou 09 Burkina Faso
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 30/07/2012 Comité d'éthique- Ecole de Santé Publique - Université de Kinshasa
Ethics Committee Address
Street address City Postal code Country
BP 11850 Kinshasa I
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 02/11/2012 Comité de bioéthique pour la recherche en santé
Ethics Committee Address
Street address City Postal code Country
Lomé Togo
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 07/06/2012 Cross River state Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Calabar Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Polymerase Chain Reaction (PCR) corrected 28 day parasitological cure rate Day 28
Secondary Outcome Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 14 day 14
Secondary Outcome Polymerase Chain Reaction (PCR) corrected parasitological cure rate at day 42 day 42
Secondary Outcome Parasitological uncorrected cure rate at day 3 day 3
Secondary Outcome Parasitological uncorrected cure rate at day 7 day 7
Secondary Outcome Parasitological uncorrected cure rate at day 14 day 14
Secondary Outcome Parasitological uncorrected cure rate at day 28 day 28
Secondary Outcome Parasitological uncorrected cure rate at day 42 day 42
Secondary Outcome Number of patients with parasitaemia at 72 hours after treatment initiation greater than or equal to 25 percent of count at baseline 72 hours
Secondary Outcome Number of patients with parasitaemia at 48 hours after treatment initiation greater than at baseline 48 hours
Secondary Outcome Time to parasite clearance (PCT) Up to 7 days
Secondary Outcome Time to fever clearance (FCT) Up to 7 days
Secondary Outcome Time to gametocyte clearance (GCT) Up to 7 days
Secondary Outcome Gametocyte carriage over time Up to 42 days
Secondary Outcome Incidence of adverse events (AEs) Up to day 42
Secondary Outcome Biochemical and haematological changes Up to day 42
Secondary Outcome Parasite reduction at 24 hours after treatment initiation 24 hours
Secondary Outcome Incidence of serious adverse events (SAEs) Up to day 365
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Service de Pédiatrie, CHU-Tokoin BP 8881 Lome Togo
Unité de Recherche Clinique de Nanoro (URCN) CMA Saint Camille de Nanoro 01 BP 1047 Ouagadougou 01 Burkina Faso
Ecole de Santé publique/Université de kinshasa/Commune de Lemba/Kinshasa Kinshasa Democratic Republic of the Congo
HOMEL (Hopital de la Mere et de l'Enfant) 01 BP 107 Cotonou Benin
Centre National de Recherche et de Formation sur le Paludisme (CNRFP) - Banfora 01 BP 2208 Ouagadougou 01 Burkina Faso
Department of Paediatrics, University of Calabar Teaching Hospital PMB 1278 Calabar Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Novartis Pharma AG Postfach Basle 4002 Switzerland
Medicines for Malaria Venture (MMV) 20 route de Pre Bois Geneva 1215 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Novartis Pharma AG Postfach Basle 4002 Switzerland Commercial Sector/Industry
Secondary Sponsor Medicines for Malaria venture (MMV) 20, Route de Pré Bois Geneva 15 1215 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Medicines for Malaria Venture (MMV) 20, rte de Pré-Bois Geneva 15 1215 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maroufou Jules Alao amomj@yahoo.fr +229 97480733
City Postal code Country Position/Affiliation
Cotonou Benin
Role Name Email Phone Street address
Public Enquiries Study Director clinicaltrial.enquiries@novartis.com + 41 61 324 1111
City Postal code Country Position/Affiliation
Switzerland
Role Name Email Phone Street address
Scientific Enquiries Study Director clinicaltrial.enquiries@novartis.com + 41 61 324 1111
City Postal code Country Position/Affiliation
Switzerland
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information