Condition category
Infections and Infestations
Date applied
15/11/2007
Date assigned
15/11/2007
Last edited
15/11/2007
Prospective/Retrospective
Prospectively 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
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3469
ringwaldp@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC243

Study information

Scientific title

Acronym

Study hypothesis

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

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)

Study design

One arm non-comparative study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Artesunate, sulfadoxine-pyrimethamine, chloroquine

Primary outcome measures

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

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/11/2007

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300

Participant 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)

Recruitment start date

15/11/2007

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Afghanistan

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3469
ringwaldp@who.int

Sponsor type

Research organisation

Website

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

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