Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001039875
Ethics application status
Approved
Date submitted
24/09/2012
Date registered
28/09/2012
Date last updated
28/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic efficacy study of artemether-lumefantrine and artesunate-amodiaquine in the treatment of uncomplicated Plasmodium falciparum malaria at two sentinel sites in Togo
Scientific title
Therapeutic efficacy study of artemether-lumefantrine and artesunate-amodiaquine in the treatment of uncomplicated Plasmodium falciparum malaria at two sentinel sites in Togo
Secondary ID [1] 281304 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
uncomplicated falciparum malaria 287502 0
Condition category
Condition code
Infection 287830 287830 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Artemether-lumefantrine tablets, each containing 20 mg of artemether and 120 mg of lumefantrine, will be administered twice daily for 3 consecutive days. Children with body weight of 5-14 kg will receive one tablet morning and evening and chidren from 15 kg up to 24 kg will received 2 tablets morning and evening. Patients treated with artesunate plus amodiaquine will be administered oral tablets of artesunate at a dose of 4 mg/kg/day up to a maximum of 250 mg per day and oral tablets of amodiaquine at a dose of 10/kg/day up to a maximum of 600 mg per day for three consecutive days. Patients will be observed for 28 days follwoing initiation of treatment. Artemether-lumefantrine and artesunate plus amodiaquine treatments correspond to the first and second line antimalarial treament policy (standard of care) in Togo, respectivlely.
Intervention code [1] 285761 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288050 0
PCR adjusted adequate clinical and parasitological response at Day 28 (percent of treatment failures (early + late clinical failure + late parasitological failureas defined in the latest WHO protocol for monitoring therapeutic efficacy of antimalarial drugs.
Timepoint [1] 288050 0
Day 28 following initiation of treatment
Secondary outcome [1] 299340 0
Percent of adverse events will be documented. Possible adverse events, related or not to the medicines, include dizziness, itching, vomiting abdominal pain, flatulence, headache, bodyache, diarrhoea, tinnitus, increased hair loss, macular rash, reduction in neurophil counts, convulsions
Timepoint [1] 299340 0
Day 28 following initiation of treatment

Eligibility
Key inclusion criteria
age between 6 and 59 months
microscopically confirmed monoinfection with P falciparum
parasitemia (asexual forms) between 2000 and 200 000 per microliter
fever (body temperature of 37.5 C or greater)
able to swallow medication
able to comply with protocol assessment schedule
Minimum age
6 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
clinical signs and symptoms of severe malaria
infection with another Plasmodium species or co-infection
severe malnutrition
fever due to other diseases

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 4569 0
Togo
State/province [1] 4569 0

Funding & Sponsors
Funding source category [1] 286052 0
Government body
Name [1] 286052 0
World Health Organisation
Country [1] 286052 0
Switzerland
Primary sponsor type
Government body
Name
Ministere de la Sante du Togo
Address
Angle Avenue du 24 Janvier et avenue Sarakawa
Country
Togo
Secondary sponsor category [1] 284865 0
None
Name [1] 284865 0
Address [1] 284865 0
Country [1] 284865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288104 0
WHO ERC
Ethics committee address [1] 288104 0
20 Avenue Appia
CH1211
Geneva
Ethics committee country [1] 288104 0
Switzerland
Date submitted for ethics approval [1] 288104 0
Approval date [1] 288104 0
12/09/2012
Ethics approval number [1] 288104 0
RPC536

Summary
Brief summary
To monitor the efficacy and safety of artemether-lumefantrine and artesunate amodiaquine in the treatment of uncomplicated falciparum malaria in two sentinel sites in Togo
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34752 0
Address 34752 0
Country 34752 0
Phone 34752 0
Fax 34752 0
Email 34752 0
Contact person for public queries
Name 17999 0
Dr AM Dorkendoo
Address 17999 0
Medicine and Pharmacy Faculty
Universtiy of Lome
BP1515 Lome
Country 17999 0
Togo
Phone 17999 0
+228 90 04 44 17
Fax 17999 0
Email 17999 0
[email protected]
Contact person for scientific queries
Name 8927 0
Dr AM Dorkendoo
Address 8927 0
Medicine and Pharmacy Faculty
Universtiy of Lome
BP 1515 Lome
Country 8927 0
Togo
Phone 8927 0
+228 90 04 44 17
Fax 8927 0
Email 8927 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.