Efficacy and safety of artesunate and sulfadoxine-pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of vivax malaria in Nangarhar, Takhar and Faryab provinces, Afghanistan

ISRCTN	ISRCTN40223079
DOI	https://doi.org/10.1186/ISRCTN40223079
Protocol serial number	RPC243
Sponsor	World Health Organization (WHO) (Switzerland)
Funder	World Health Organization (WHO) (Switzerland)

Submission date: 15/11/2007
Registration date: 15/11/2007
Last edited: 15/11/2007

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 Pascal Ringwald
Scientific

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

Phone	+41 (0)22 791 3469
Email	ringwaldp@who.int

Study information

Primary study design	Interventional
Study design	One arm non-comparative study
Secondary study design	Non randomised controlled trial
Scientific title
Study objectives	Monitor efficacy and safety of artesunate and sulfadoxine-pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of vivax malaria.
Ethics approval(s)	Ethics approval received from: 1. Ministry of Public Health Afghanistan on the 15th September 2007 2. World Health Organization (WHO) Ethics Review Committee (ERC) on the 13th November 2007 (ref: RPC 243)
Health condition(s) or problem(s) studied	Malaria
Intervention	1. Artesunate (12 mg/kg) and sulfadoxine (25 mg/kg single dose) - pyrimethamine (1.25 mg/kg single dose) over 3 days for falciparum malaria 2. Chloroquine 25 mg/kg over 3 days for vivax malaria Contact details for Principal Investigator: Dr Ghulam Rahim Awab District/Phase - 4 Jalalabad City Nangarhar Afghanistan Tel: +93 (0)70 004 4853 Email: awabgr@yahoo.com
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artesunate, sulfadoxine-pyrimethamine, chloroquine
Primary outcome measure(s)	1. To measure the clinical and parasitological efficacy of artesunate and sulfadoxine-pyrimethamine among patients aged above six months suffering from uncomplicated falciparum malaria and chloroquine for vivax malaria, by determining the proportion of patients with: 1.1. Early Treatment Failure (ETF) 1.2. Late Clinical Failure (LTF) 1.3. Late Parasitological Failure (LPF) 1.4. Adequate Clinical and Parasitological Response (ACPR) As indicators of efficacy 2. To differentiate recrudescences from new infections by the Polymerase Chain Reaction (PCR) analysis 3. To evaluate the incidence of adverse events
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/02/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Age above 6 months 2. Mono-infection with P. falciparum or P. vivax 3. Parasitaemia, 1000 - 100,000 asexual forms per µl for falciparum malaria and above 250 asexual forms per µl for vivax malaria 4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C 5. Ability to swallow oral medication 6. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 7. Informed consent from the patient or from a parent or guardian in case of children
Key exclusion criteria	1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions (see Annex 1) 2. Mixed or mono-infection with another Plasmodium species 3. Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the National Center for Health Statistics [NCHS]/WHO normalised reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] less than 110 mm) 4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrome [AIDS]) 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment 6. Positive pregnancy test or lactating (if adults included)
Date of first enrolment	15/11/2007
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

Afghanistan
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan