Condition category
Infections and Infestations
Date applied
17/04/2007
Date assigned
03/05/2007
Last edited
22/03/2013
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 Olumide Ogundahunsi

ORCID ID

Contact details

Manager
MIM/TDR Task Force on Malaria Research Capability Strengthening in Africa
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A60100

Study information

Scientific title

Acronym

Study hypothesis

The effectiveness of Coartem® would be equal to efficacy given good compliance.

Ethics approval

Approval received from the ethics board of the National Institute of Medical Research Board on the 1st August 2006 (ref: NIMR/HQ/R.8a/Vol. IX/344).

Study design

Clinical research

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Malaria in under five children

Intervention

In this clinical trial there is no intervention apart from early diagnosis and prompt treatment.

Patients will be treated with Artemether-lumefantrine (Coartem®), given either under supervision or by their parents. Treatment with Coartem® will be for three days, and the patients will be followed up on the following days:

Under supervision: follow-up on days 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56
Drugs given by parent: follow-up on days 1, 7, 14, 21, 2, 35, 42, 49, 56

If the treatment is a clinical failure after day 14, or a parasitological failure after day 56, then the patient will again be treated for three days with Coartem®, and will be followed up on the following days:

Under supervision: follow-up on days 1, 2, 3, 7, 14, 21, 28, 35, 42
Drugs given by parent: follow-up on days 1, 7, 14, 21, 2, 35, 42

If the treatment is a clinical failure after day 14, or a parasitological failure after day 42, then the patient is treated with quinine.

Principal Investigator:
Professor Zul Premji
Muhimbili University College of Health Sciences
Box 65011
Dar es Salaam
United Republic of Tanzania
Tel: +255 (0)754 304 468
Email: zpremji@muchs.ac.tz

Intervention type

Drug

Phase

Not Specified

Drug names

Artemether-lumefantrine (Coartem®)

Primary outcome measures

Polymerase Chain Reaction (PCR)-adjusted parasitological treatment response (cure, treatment failure) on days 14, 28, 42 and 56 after initial treatment, and on days 14, 28 and 42 after retreatment in supervised and unsupervised patients.

Secondary outcome measures

1. Occurrence of adverse events during 56 and 42 days after initial and retreatment
2. Recrudescence after initial and retreatment
3. Reinfection after initial treatment

Overall trial start date

01/03/2007

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males or females less than five years of age with body weight greater than 5 kg
2. Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 2,000 to 200,000 parasites/µl
3. Presenting with fever (axillary temperature equal to 37.5°C) or having a history of fever in the preceding 24 hours
4. Able to ingest tablets orally (either suspended in water or un-crushed with food)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

360

Participant exclusion criteria

1. Present with any of the danger signs of severe malaria
2. Signs/symptoms indicating severe/complicated malaria according to World Health Organization (WHO) criteria (WHO definition)
3. Serious gastrointestinal disease, severe malnutrition (Weight-for-Height [W/H] less than 70%) or severe anaemia (haemoglobin less than 5 g/dl)
4. Known hypersensitivity to artemether-lumefantrine
5. Have been treated with any other drugs within eight weeks prior to screening or intend to use other drugs or biologics during the study

Recruitment start date

01/03/2007

Recruitment end date

01/12/2009

Locations

Countries of recruitment

Tanzania

Trial participating centre

Manager
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.who.int/tdr/diseases/malaria/mim.htm

Funders

Funder type

Research organisation

Funder name

Multilateral Initiative on Malaria (MIM)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21427394
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23506218?

Publication citations

  1. Results

    Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, Bergqvist Y, Gil JP, Premji Z, Björkman A, Mårtensson A, Efficacy and effectiveness of artemether-lumefantrine after initial and repeated treatment in children <5 years of age with acute uncomplicated Plasmodium falciparum malaria in rural Tanzania: a randomized trial., Clin. Infect. Dis., 2011, 52, 7, 873-882, doi: 10.1093/cid/cir066.

  2. Malmberg M, Ngasala B, Ferreira PE, Larsson E, Jovel I, Hjalmarsson A, Petzold M, Premji Z, Gil JP, Björkman A, Mårtensson A, Temporal trends of molecular markers associated with artemether-lumefantrine tolerance/resistance in Bagamoyo district, Tanzania., Malar. J., 2013, 12, 103, doi: 10.1186/1475-2875-12-103.

Additional files

Editorial Notes