Effectiveness and pharmacovigilance of Lapdap™ and Coartem® for the treatment of uncomplicated falciparum malaria in northeastern Tanzania

ISRCTN ISRCTN08525528
DOI https://doi.org/10.1186/ISRCTN08525528
Secondary identifying numbers A40744
Submission date
31/03/2006
Registration date
31/03/2006
Last edited
10/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ahmed Bellah
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesLapdap™ is likely to be as effective as Coartem® in malaria management when used in an unsupervised situation.
Ethics approval(s)Ethics approval received on the 10th July 2005.
Health condition(s) or problem(s) studiedMalaria
InterventionLapdap™ versus Coartem®.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Lapdap™, Coartem®
Primary outcome measureTo assess the effectiveness of Lapdap™ and Coartem® through clinical and parasitological responses.
Secondary outcome measures1. 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 study start date01/06/2006
Completion date01/10/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit59 Months
SexBoth
Target number of participants2600
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment01/06/2006
Date of final enrolment01/10/2007

Locations

Countries of recruitment

  • Switzerland
  • Tanzania

Study participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website http://www.who.int
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Industry

Gates Foundation (USA)

No information available

Glaxo SmithKline (GSK) (USA) - donating the Lapdap™ free of charge

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan