Evaluate impact of rectal artesunate on resolution of severe malaria and mortality (Bangladesh)

ISRCTN	ISRCTN83979018
DOI	https://doi.org/10.1186/ISRCTN83979018
Secondary identifying numbers	N/A

Submission date: 01/02/2006
Registration date: 01/02/2006
Last edited: 23/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Melba Gomes
Scientific

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	The objective has been to establish whether, in patients with acute malaria who cannot take medication by mouth, rectal artesunate plus referral differs from rectal placebo plus referral in terms of death or permanent disability.
Ethics approval(s)	Ethics approval received on the 8th July 1998.
Health condition(s) or problem(s) studied	Malaria
Intervention	The sample size determination in the protocol specified that a total of 10,000 non per os patients would need to be randomised in order to detect a reduction of mortality from 5% to 3%. Individual patients will be randomised to receive either AS suppository (intervention group) or placebo (comparator group). Patients in both groups will then be referred immediately to the nearest hospital/health centre where all supportive treatment will be provided.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artesunate (AS)
Primary outcome measure	1. Number of relevant deaths in the intervention and control arm assessed 7 - 30 days after enrolment (relevant defined as malaria positive patients in whom the death was probably/definitely preventable by the intervention) 2. Number of individuals with serious neurological disability in the intervention and control arms assessed at 7 - 30 days following enrolment in the study. Neurological disability defined as the development of new problems with feeding, walking, talking, sitting, sight, hearing, playing, balance and behaviour
Secondary outcome measures	1. Number of deaths in the intervention and control arm assessed 7 - 30 days following enrolment in the study 2. Number of cases of neurological disability in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 3. Number of cases of neurological disability in malaria smear positive patients in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 4. Number of cases of neurological disability in children in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 5. Number of cases of neurological disability in pregnant women in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 6. Number of deaths and neurological sequelae in the intervention and control arm in malaria smear positive patients who survived at least 8 hours but died before 7 days after enrolment in the study
Overall study start date	08/07/1998
Completion date	08/07/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	In this trial, it is not the number of patients recruited but the number of deaths that determine the statistical power of such a trial.
Key inclusion criteria	1. Children above crawling age and adults of any age group 2. Clinical diagnosis of probable P. falciparum malaria (fever, or history of fever without any other obvious cause of fever). Clinical features must include fever or history of fever and at least one of the following: 2.1. Unable to take food, drink or suck 2.2. Prostration: inability to sit, stand or walk unaided 2.3. Any abnormal level of consciousness i.e. from abnormal behavior, obtunded (limited response to painful stimulus), to coma (unconsciousness with absent verbal response and non-specific or absent motor response) 2.4. Fits or history of fits (defined as more than one fit in the previous 24 hours) 3. Consent by patient or parent/guardian if patient is less than 18 4. Community informed consent - at the start of the study in that area, community consent to the project would have been obtained
Key exclusion criteria	1. Afebrile (history/examination) 2. Unwillingness to sign (or parental signature) informed consent for study participation 3. Ability to take oral medication 4. Diarrhoea (at least two loose bowel movements in the previous two hours) N.B. Pregnant or breast-feeding women will not be excluded from the study. Status of pregnancy in female will be noted in the Case Record Form (CRF).
Date of first enrolment	08/07/1998
Date of final enrolment	08/07/2000

Locations

Countries of recruitment

Bangladesh
Switzerland

Study participating centre

20, Avenue Appia

Geneva-27
CH 1211
Switzerland

Sponsor information

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

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

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

Funders

Funder type

Research organisation

Sources of funding:

No information available

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

European Commission (Belgium)
Government organisation / National government

Alternative name(s): European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU

WHO Global Malaria Programme

No information available

US Agency for International Development (USAID) (USA)

No information available

Irish Aid (Ireland)

No information available

Karolinska Institutet (Sweden)
Government organisation / Local government

Alternative name(s): Karolinska Institute, KI
Location: Sweden

Sall Family Foundation (USA)
Private sector organisation / Trusts, charities, foundations (both public and private)

Location: United States of America

University of Oxford Clinical Trial Service Unit (UK)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/02/2009		Yes	No