Condition category
Infections and Infestations
Date applied
15/05/2008
Date assigned
15/05/2008
Last edited
19/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pascal Ringwald

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 34 69
ringwaldp@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Pakistan 1

Study information

Scientific title

Acronym

Study hypothesis

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

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)

Study design

One arm non-blinded clinical surveillance trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Artesunate, sulfadoxine-pyrimethamine

Primary outcome measures

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 trial start date

21/01/2008

Overall trial end date

06/01/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

300

Participant 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)

Recruitment start date

21/01/2008

Recruitment end date

06/01/2009

Locations

Countries of recruitment

Pakistan

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 34 69
ringwaldp@who.int

Sponsor type

Research organisation

Website

http://www.who.int/malaria.html

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes