Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Eritrea

ISRCTN ISRCTN79195095
DOI https://doi.org/10.1186/ISRCTN79195095
Secondary identifying numbers RPC239; Eritrea2
Submission date
07/09/2007
Registration date
07/09/2007
Last edited
15/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pascal Ringwald
Scientific

World Health Organization
20 Avenue Appia
Geneva 27
CH-1211
Switzerland

Phone +41 (0)22 791 34 69
Email ringwaldp@who.int

Study information

Study designClinical trial, surveillance, single arm study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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(s)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)
Health condition(s) or problem(s) studiedMalaria
InterventionArtemether 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Artemether-lumefantrine
Primary outcome measureTo measure the clinical and parasitological efficacy (Adequate Clinical and Parasitological Response [ACPR]).
Secondary outcome measures1. To differentiate recrudescence from new infections by the Polymerase Chain Reaction (PCR) analysis
2. To measure the clinical and parasitological efficacy PCR corrected
Overall study start date03/09/2007
Completion date03/03/2008

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants180
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment03/09/2007
Date of final enrolment03/03/2008

Locations

Countries of recruitment

  • Eritrea
  • Switzerland

Study participating centre

World Health Organization
Geneva 27
CH-1211
Switzerland

Sponsor information

World Health Organization (WHO) (Switzerland)
Research organisation

20 Avenue Appia
Geneva 27
CH-1211
Switzerland

Phone +41 (0)22 791 34 69
Email ringwaldp@who.int
Website http://www.who.int/malaria/
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Alternative name(s)
منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan