Condition category
Infections and Infestations
Date applied
07/09/2007
Date assigned
07/09/2007
Last edited
15/10/2008
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

RPC239; Eritrea2

Study information

Scientific title

Acronym

Study hypothesis

The general objective of this study is to assess the therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria in three sentinel sites in Eritrea.

Ethics approval

Ethics approval gained from:
1. Ministry of Health Eritrea on the 18th July 2007 (ref: 15124/6716/07)
2. Research Ethics Review Committee of the World Health Organization (ERC WHO) on the 28th August 2007 (ref: RPC239)

Study design

Clinical trial, surveillance, single arm 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

Artemether and lumefantrine six doses over three days orally (per os) according to manufacturer recommendations. As this is a surveilllance study there is no control group.

Contact details of Principal Investigator:
Dr Tewolde Ghebremeskel Woldeghabir
Ministry of Health
Asmarat
P.O. Box 212
Eritrea
Tel: +291 (0)1 125 529
Fax: +291 (0)1 122 899
Email: tewoldeg@moh.gov.er or tewoldeg2003@yahoo.com

Intervention type

Drug

Phase

Not Specified

Drug names

Artemether-lumefantrine

Primary outcome measures

To measure the clinical and parasitological efficacy (Adequate Clinical and Parasitological Response [ACPR]).

Secondary outcome measures

1. To differentiate recrudescence from new infections by the Polymerase Chain Reaction (PCR) analysis
2. To measure the clinical and parasitological efficacy PCR corrected

Overall trial start date

03/09/2007

Overall trial end date

03/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. All ages, 6 months and above
2. Single infection with P. falciparum
3. Parasitaemia of 1,000 - 100, 000 asexual forms per µl
4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C, or history of fever in the previous 24 hours
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

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 (SD)
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. Pregnancy or positive pregnancy test or lactating

Recruitment start date

03/09/2007

Recruitment end date

03/03/2008

Locations

Countries of recruitment

Eritrea

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/

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