Condition category
Infections and Infestations
Date applied
14/08/2007
Date assigned
15/08/2007
Last edited
11/09/2007
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

RPC220

Study information

Scientific title

Acronym

Study hypothesis

To assess the efficacy of the first (artesunate and sulfadoxine-pyrimethamine) and second line treatment (artemether-lumefantrine) for the treatment of uncomplicated Plasmodium falciparum infections in different sentinel sites in Sudan.

Ethics approval

Ethics approval received from:
1. Federal Ministry of Health (Sudan) on the 3rd May 2007
2. Ethical Research Committee of the World Health Organization (WHO) on the 11th June 2007 (ref: RPC220)

Study design

One-arm surveillance study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malaria

Intervention

Each patient will receive both:
1. Artemether-lumefantrine six consecutive doses according to manufacturer recommendation over three days orally (per os)
2. Artesunate 12 mg/kg over three days per os and sulfadoxine-pyrimethamine 1/2 tablet 500 mg - 25 mg/10 kg single dose per os

Principal Investigator:
Dr Khalid A. Elmardi
National Malaria Control Programme
Federal Ministry of Health
P.O. Box 1204
Khartoum
Sudan
Tel: +249 (0)183 776809
Fax: +249 (0)183 770397
Email: khalidmrd9@hotmail.com

Intervention type

Drug

Phase

Not Specified

Drug names

Artesunate, sulfadoxine-pyrimethamine, artemether-lumefantrine

Primary outcome measures

Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected.

Secondary outcome measures

Incidence of adverse events.

Overall trial start date

01/08/2007

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 6 months old
2. Infection with P. falciparum
3. Parasitaemia, 1000 - 100 000 asexual forms per µl
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

Not Specified

Gender

Not Specified

Target number of participants

180

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
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 who has symmetrical oedema involving at least the feet)
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
5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
6. Pregnancy or lactation

Recruitment start date

01/08/2007

Recruitment end date

30/11/2007

Locations

Countries of recruitment

Sudan

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO)/HIV/AIDS, Tuberculosis and Malaria (HTM) - Global Malaria Programme

Sponsor details

20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

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

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Sudan)

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