Condition category
Infections and Infestations
Date applied
31/03/2006
Date assigned
31/03/2006
Last edited
10/09/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ahmed Bellah

ORCID ID

Contact details

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

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 measures

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

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

http://www.who.int

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes