Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A40744
Study information
Scientific title
Acronym
Study hypothesis
Lapdap™ is likely to be as effective as Coartem® in malaria management when used in an unsupervised situation.
Ethics approval
Ethics approval received on the 10th July 2005.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Malaria
Intervention
Lapdap™ versus Coartem®.
Intervention type
Drug
Phase
Not Specified
Drug names
Lapdap™, Coartem®
Primary outcome measure
To assess the effectiveness of Lapdap™ and Coartem® through clinical and parasitological responses.
Secondary outcome measures
1. To document the frequency and type of potential drug related adverse events
2. To assess community compliance and acceptability of Lapdap™ and Coartem® use
3. To determine the prevalence and to monitor the development of dhfr/dhps gene mutations which are markers of resistance
Overall trial start date
01/06/2006
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 6 and 59 months (although the lower age limit for Lapdap™ use is three months according to the label, malaria is rare among those below six months of age)
2. Weight of 5 - 16 kg
3. Presence of fever (axillary temperature greater than or equal to 37.5°C) and/or history of fever within two days
4. Uncomplicated malaria, slide-confirmed mono-infection of P. falciparum with 1000 - 100,000 rings/µl
5. The ability to attend follow-up visits
6. Informed consent provided by parent or guardian
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2600
Participant exclusion criteria
1. Malnutrition, defined as a child whose weight-for-height is below -3 SDs or less than 70% of the median of the National Center for Health Statistics (NCHS)/World Health Organization (WHO) normalised reference values
2. Known history of G6PD defficiency, methaaemogloin reductase deficiency, Haemoglobin M or E, or porphyria
3. Evidence of severe malaria as defined in WHO 2000
4. Hb equal to or less than 7 g/dl
5. Hypersensitivity to biguanides (e.g. proguanil, chlorproguanil) or sulphonamides such as fancidar and septrin
6. Evidence of concomitant fibrile infection
7. Treatment with antimalarial drugs within the past 14 days or 7 days with quinine (full course), proguanil, artemisinins, tetracycline doxycycline or clindamycin. Patient shall not be excluded on the basis of reported prior treatment with other anti-malarial drugs within the past 24 hours if they have a temperature and parasitemia.
Recruitment start date
01/06/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
Tanzania
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Gates Foundation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Glaxo SmithKline (GSK) (USA) - donating the Lapdap™ free of charge
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list