Condition category
Infections and Infestations
Date applied
05/04/2005
Date assigned
07/06/2005
Last edited
15/08/2008
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 Melba Gomes

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3813
gomesm@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A20210 and A70334

Study information

Scientific title

Acronym

Study hypothesis

Hypothesis that clinical response rates in children aged 3 to 24 months with non per os malaria treated with rectal artesunate will not be inferior to those who receive standard treatment of parenteral Quinine.

Please note that as of 15/08/2008, this record was updated to include Tanzania in the countries of recruitment list. This country started recruitment on 08/05/2008 and was added in order to add to the patient numbers. Ethics approval for this site has also been added to this record, and the anticipated end date has also been updated. The previous anticipated end date for this trial was 30/09/2007.

Ethics approval

Approved by:
1. The Committee on Human Research Publication and Ethics (CHRPE) of the School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi on 20th January 2003
2. World Health Organization (WHO) Ethics Committee on 30th June 2003 and continuing review 15th November 2005 and 13 November 2007
3. The National Institute of Medical Research, Tanzania on 28th August 2007

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

Group A: Artesunate 10 mg/kg, rectal
Group B: Quinine 20 mg dihydrochloride salt/kg, intra-muscular injection (followed by 10 mg/kg at 12 and 24 hours)

Intervention type

Drug

Phase

Not Specified

Drug names

Artesunate, quinine

Primary outcome measures

28-day disease-free survival, defined as patients who survived the 28-day period of follow-up with the peripheral blood free of the original genotype of malaria parasites.

Secondary outcome measures

The parasitological outcomes and tolerability of a single dose of the rectal artesunate in children aged 3 to 24 months with non per os falciparum malaria.

Overall trial start date

30/06/2003

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 3 to 24 months
2. Suspected malaria with no other obvious cause of illness
3. P. falciparum asexual parasitaemia greater than ++ (5 - 10 parasites/High Power Field [HPF])
4. Unable to eat, suck or drink, or repeatedly vomiting (more than three episodes over past 24 hours); or prostrate (unable to sit or stand if previously able to do so)
5. History of convulsions over the preceding 24 hours or impaired consciousness (Blantyre Coma Score less than five)
6. Parent/guardian informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

246

Participant exclusion criteria

1. Ability to tolerate oral intake
2. Acute diarrhoea defined as the presence of more than three episodes of watery stools in the preceding 24 hours
3. History of allergy to artemisinin compounds and/or quinine

Recruitment start date

30/06/2003

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Ghana, 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

Research organisation

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