Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000586718
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
24/05/2013
Date last updated
24/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Updating the efficacy study of artemether-lumefantrine for the treatment of uncomplicated P falciparum malaria in sentinel sites in the Comoros Islands.
Scientific title
Safety and efficacy, in terms of adequate clinical and parasitological response, of artemether lumefantrine for the treatment of children with uncomplicated P. falciparum malaria in Comoros Islands.
Secondary ID [1] 282535 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
uncomplicated falciparum malaria 289202 0
Condition category
Condition code
Infection 289532 289532 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Therapeutic efficacy study of the fixed combination of artemether-lumefantrine ( 20 mg artemether/ 120 mg lumefantrine) administered orally twice a day for three consecutive days. The number of tablets to be administered at each dosing day will be based on body weight as per standard of care. Patients will be seen daily for the first three days and then return to the health center weekly (day 7, 14, 21 and 28) for clinical and parasitological evaluation or any other day if symptoms re-occurred.
Intervention code [1] 287201 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289628 0
Proportion of patients with adequate clinical and parasitological response adjusted by PCR (polymerase chain reaction)
Timepoint [1] 289628 0
Day 28
Secondary outcome [1] 302889 0
Nature and incidence of adverse events as observed by investigators or reported by patients. Clinical laboratory testing may be performed to confirm a diagnosis. Possible adverse events include those know to occur with such antimalarial and include, headache, nausea, abdominal discofort, dizziness.
Timepoint [1] 302889 0
Day 28

Eligibility
Key inclusion criteria
Age between 6 months to 11 years (inclusive);
Monoinfection with P falciparum, microscopically confirmed
Parasitaemia between 500-200,000 per microliter (asexual forms)
Axillary temperature equal or greater than 37.5 degrees C;
Able to swallow oral medication;
Capable and willing to fulfill protocol requirements, including the schedule of assessments for the duration of the study;
Provide written informed consent (parent or guardian)
Minimum age
6 Months
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of general danger and signs in children under 5 years or signs of severe falciparum malaria;
Mixed or mono-infection with another Plasmodium species detected by microscopy;
History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments(s);
Severe malnutrition (per WHO definition);
Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea);
Regular medication, which may interfere with antimalarial pharmacokinetics

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
560
Accrual to date
Final
Recruitment outside Australia
Country [1] 5092 0
Comoros
State/province [1] 5092 0
Ngazidja
Country [2] 5093 0
Comoros
State/province [2] 5093 0
Mwali
Country [3] 5094 0
Comoros
State/province [3] 5094 0
Ndzouani

Funding & Sponsors
Funding source category [1] 287317 0
Government body
Name [1] 287317 0
Ministere de la Sante, de la Solidarite et de la Promotion du Genre
Country [1] 287317 0
Comoros
Funding source category [2] 287318 0
Other
Name [2] 287318 0
World Health Organisation
Country [2] 287318 0
Switzerland
Primary sponsor type
Government body
Name
Ministere de la Sante, de la Solidarite et de la Promotion du Genre
Address
Centre National de Lutte contre le Paludisme/
C/O Organisation Mondiale de la Sante
Itsambouni
B.P. 435
Moroni, Grande Comore
Country
Comoros
Secondary sponsor category [1] 286066 0
None
Name [1] 286066 0
Address [1] 286066 0
Country [1] 286066 0
Other collaborator category [1] 277416 0
University
Name [1] 277416 0
Institut Pasteur de Madagascar
Address [1] 277416 0
B.P. 1274
Ambatofotsikely
101 Antananarivo
Country [1] 277416 0
Madagascar

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289290 0
WHO ERC
Ethics committee address [1] 289290 0
World Health Organisation
20 Avenue Appia
1211 Geneva
Ethics committee country [1] 289290 0
Switzerland
Date submitted for ethics approval [1] 289290 0
20/03/2013
Approval date [1] 289290 0
14/05/2013
Ethics approval number [1] 289290 0
RPC570

Summary
Brief summary
Therapeutic efficacy study of the fixed combination of artemether-lumefantrine (20 mg artemether/ 120 mg lumefantrine) administered orally twice a day for three consecutive days. The number of tablets per dosing will be based on body weight per standard of care. Patients will be seen daily for the first three days and then return to the health center weekly (day 7, 14, 21 and 28) for clinical and parasitological evaluation or any other day if symptoms re-occurred.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40206 0
Mrs Rahamatou SILAI
Address 40206 0
Ministere de la Sante, de la Solidarite et de la Promotion du Genre a l'Union des Comores
C/O Organisation Mondiale de la Sante
Itsambouni
B.P. 435
Moroni
Grande Comore
Country 40206 0
Comoros
Phone 40206 0
+2693330375
Fax 40206 0
Email 40206 0
[email protected]
Contact person for public queries
Name 40207 0
Mrs Rahamatou SILAI
Address 40207 0
Ministere de la Sante, de la Solidarite et de la Promotion du Genre a l'Union des Comores
C/O Organisation Mondiale de la Sante
Itsambouni
B.P. 435
Moroni
Grande Comore
Country 40207 0
Comoros
Phone 40207 0
+2693330375
Fax 40207 0
Email 40207 0
[email protected]
Contact person for scientific queries
Name 40208 0
Mrs Rahamatou SILAI
Address 40208 0
Ministere de la Sante, de la Solidarite et de la Promotion du Genre a l'Union des Comores
C/O Organisation Mondiale de la Sante
Itsambouni
B.P. 435
Moroni
Grande Comore
Country 40208 0
Comoros
Phone 40208 0
+2693330375
Fax 40208 0
Email 40208 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.