Condition category
Infections and Infestations
Date applied
17/04/2007
Date assigned
25/05/2007
Last edited
10/09/2007
Prospective/Retrospective
Retrospectively 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 Franco Pagnoni

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

A60486

Study information

Scientific title

Acronym

Study hypothesis

Community level treatment of malaria and/or acute respiratory infections guided by malaria Rapid Diagnostic Testing (RDT) and respiratory rate counting improves clinical recovery rate of children with febrile disease.

Ethics approval

Approval received from the Comité d’ethique pour la Recherche en Santé du Burkina (CERS-B) on the 15th February 2007.

Study design

Open randomised, controlled, clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Malaria, acute respiratory infection

Intervention

Patients were randomised between:
1. Treatment with Coartem® and/or cotrimoxazole based on rapid diagnosis test results and respiratory rate count
2. Presumptive treatment with Coartem®, on day three after the onset of the treatment

Principal Investigator:
Tiono Alfred
Centre National de Recherche et de Formation sur le Paludisme
01 BP 2208
Ouagadougou 01
Burkina Faso
Tel: +226 70 28 57 26
Email: t.alfred@fasonet.bf

Intervention type

Drug

Phase

Not Specified

Drug names

Coartem®, cotrimoxazole

Primary outcome measures

Clinical recovery rate at 72 hours after treatment (defined as apyrexia and axillary temperature less than 37.5°C).

Secondary outcome measures

1. Evaluate influence of the seasonal variation of malaria transmission on the impact, measured at eight days post onset of the treatment
2. Assess the cost-effectiveness of RDT in the context of the HMM strategy with Coartem®, measured at the end of the study
3. Describe the operational feasibility and acceptability of RDT in the context of the HMM strategy with Coartem®, measured at the end of the study

Overall trial start date

01/05/2007

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent from parent/guardian
2. Aged 6 to 59 months
3. Weight equals 5 kg
4. Willing to comply with the study procedures
5. History of fever within the last 24 hours or documented fever (axillary temperature equals 37.5°C)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1200

Participant exclusion criteria

1. Severe malaria
2. Danger signs (unable to drink or eat, incoercible vomiting, convulsions, prostration)
3. History of allergic reaction to the study drugs
4. History of treatment with artemisinin derivatives in the past seven days
5. Previous participation in this study

Recruitment start date

01/05/2007

Recruitment end date

01/05/2008

Locations

Countries of recruitment

Burkina Faso

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/tdr/topics/mim/default.htm

Funders

Funder type

Research organisation

Funder name

Multilateral Initiative on Malaria (MIM)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

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