Efficacy and safety of rectal artesunate in paediatric patients - a randomised controlled study (Ghana and Tanzania)

ISRCTN	ISRCTN78768405
DOI	https://doi.org/10.1186/ISRCTN78768405
Secondary identifying numbers	A20210 and A70334

Submission date: 05/04/2005
Registration date: 07/06/2005
Last edited: 15/08/2008

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 Melba Gomes
Scientific

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

Phone	+41 (0)22 791 3813
Email	gomesm@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artesunate, quinine
Primary outcome measure	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 study start date	30/06/2003
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	24 Months
Sex	Both
Target number of participants	246
Key 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
Key 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
Date of first enrolment	30/06/2003
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

Ghana
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"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan