Assessment of antimalarial drug efficacy in uncomplicated falciparum malaria at six sentinel sites in Pakistan

ISRCTN	ISRCTN21926128
DOI	https://doi.org/10.1186/ISRCTN21926128
Secondary identifying numbers	Pakistan 1

Submission date: 15/05/2008
Registration date: 15/05/2008
Last edited: 30/12/2020

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 Pascal Ringwald
Scientific

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

Phone	+41 (0)22 791 34 69
Email	ringwaldp@who.int

Study information

Study design	One arm non-blinded clinical surveillance trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Assessment of antimalarial drug efficacy in uncomplicated falciparum malaria at six sentinel sites in Pakistan
Study objectives	1. To evaluate the proportion of patients with early treatment failure (ETF), late clinical failure (LTF), late parasitological failure (LPF), or with an adequate clinical and parasitological response (ACPR) as indicators of efficacy 2. To evaluate the incidence of adverse events 3. To formulate recommendations and to enable the Directorate of Malaria Control (DOMC) in the Ministry of Health to make informed decisions about the possible need for updating of the current national antimalarial treatment guidelines
Ethics approval(s)	Ethics approval received from: 1. World Health Organization (WHO) Ethics Review Committee (ERC) on the 16th January 2008 (ref: RPC254) 2. Ministry of Health (Pakistan) on the 1st December 2007 (ref: F.1-4/2003-ST)
Health condition(s) or problem(s) studied	Malaria
Intervention	Artesunate 4 mg/kg/day over three days and sulfadoxine-pyrimethamine 25 mg/kg and 1.25 mg/kg single dose. The treatment is three days and the follow up is 28 days. Contact details for Principal Investigator: Dr Faisal Mansoor 23c Sabir House Faisbad Rawalpindi Islamabad Pakistan Tel: +92 (0)51 441 5494 Email: faisalmansoor100@gmail.com
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artesunate, sulfadoxine-pyrimethamine
Primary outcome measure	1. To evaluate the proportion of patients with early treatment failure (ETF), late clinical failure (LTF), late parasitological failure (LPF), or with an adequate clinical and parasitological response (ACPR) as indicators of efficacy 2. To evaluate the incidence of adverse events The outcome measure is at day 28 except if the patient fails or is lost to follow-up or withdrawn from the study.
Secondary outcome measures	No secondary outcome measures
Overall study start date	21/01/2008
Completion date	06/01/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Aged over six months old, either sex 2. Uncomplicated mono-infection with Plasmodium falciparum 3. Parasitaemia, 1,000 - 100,000 asexual forms per µl 4. Axillary temperature greater than or equal to 37.5°C or oral/rectal temperature of greater than or equal to 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 five years old or other signs of severe and complicated falciparum malaria according to current WHO definitions 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 mothers (if adults included)
Date of first enrolment	21/01/2008
Date of final enrolment	06/01/2009

Locations

Countries of recruitment

Pakistan
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Sponsor information

World Health Organization (WHO) (Switzerland)
Research organisation

20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone	+41 (0)22 791 34 69
Email	ringwaldp@who.int
Website	http://www.who.int/malaria.html
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations

Alternative name(s): منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
Location: Switzerland

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	01/12/2016	30/12/2020	Yes	No

Editorial Notes

30/12/2020: Publication reference added.