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

• Register: ISRCTN
• Last refreshed on: 11 January 2021
• Main ID: ISRCTN21926128
• Date of registration: 15/05/2008
• Prospective Registration: No
• Primary sponsor: World Health Organization (WHO) (Switzerland)
• Public title: Assessment of antimalarial drug efficacy in uncomplicated falciparum malaria at six sentinel sites in Pakistan
• Scientific title: Assessment of antimalarial drug efficacy in uncomplicated falciparum malaria at six sentinel sites in Pakistan
• Date of first enrolment: 21/01/2008
• Target sample size: 300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN21926128
• Study type: Interventional
• Study design: One arm non-blinded clinical surveillance trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Pakistan

Contacts

• Name: Pascal Ringwald

Key inclusion & exclusion criteria

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

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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Infections and Infestations
Plasmodium falciparum malaria

Intervention(s)

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: [phone]
Email: [e-mail]

Primary Outcome(s)

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(s)

No secondary outcome measures

Secondary ID(s)

Pakistan 1

Source(s) of Monetary Support

World Health Organization (WHO) (Switzerland)

Ethics review

Status:
Approval date:
Contact:

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)

Results

• Results available: Yes
• Date Completed: 06/01/2009