Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000617763
Ethics application status
Approved
Date submitted
24/05/2013
Date registered
29/05/2013
Date last updated
29/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of a fixed combination of artemether and lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria using the sentinel surveillance system in Zimbabwe.
Scientific title
Therapeutic efficacy study of a fixed combination of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children and adults using the sentinel surveillance system in Zimbabwe.
Secondary ID [1] 282547 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated falciparum malaria 289217 0
Condition category
Condition code
Infection 289552 289552 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
This is a single-arm open label study to monitor the efficacy of artemether-lumefantrine, the first-line antimalarial in Zimbabwe. Eligible patients will be treated with fixed combination tablet containing 1.5 mg base artemether and 12 mg base lumefantrine. The number of tablets per dose will be determined according to body weight as per standard of care. Patients will be administered the dose by study staff twice a day for three consecutive days. Patients will be seen daily for the first 3 days and then will return to the health center for clinical and parasitological evaluation on days 7, 14, 21 and 28 or any other day if symptoms re-occurred.
Intervention code [1] 287218 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289670 0
Proportion of patients with adequate clinical and parasitological response adjusted by PCR (polymerase chain reaction) according to WHO definition
Timepoint [1] 289670 0
Day 28
Secondary outcome [1] 302981 0
Nature and incidence of adverse events. Possible adverse events are those known to occur with antimalarials and include headache, nausea, abdominal pain, fatigue, muscle pain and dizziness.
Timepoint [1] 302981 0
Day 28

Eligibility
Key inclusion criteria
Age 6 months and above;
Mono-infection with P. falciparum detected by microscopy;
Parasitaemia between 1000 to 100,000 per microliter asexual forms;
Axillary temperature equal or greater than 37.5 degrees C or history of fever within the past 24 hours;
Ability to swallow oral medication;
Ability and willingness to comply with the study protocol for the duration of the study including the study visit schedule;
Informed consent from the patient or parent
Resident within 5 km radius from study site
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of general danger signs in children under 5 years or signs of severe malaria
Mixed or mono-infection with another Plasmodium species detected by microscopy;
Presence of severe malnutrition (according to WHO definitions);
Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases;
Regular medication which may interfere with antimalarial pharmacokinetics;
History of hypersensitivity reaction or contraindications to any of the medicines being tested or used as alternative treatment;
Positive pregnancy test or breastfeeding (for women of child-bearing age);
Unable or unwilling to take a preganancy test or contraceptives;
Resident outside 5 km radius from study site

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
3/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
724
Accrual to date
Final
Recruitment outside Australia
Country [1] 5105 0
Zimbabwe
State/province [1] 5105 0
Gokwe/ Midlands
Country [2] 5106 0
Zimbabwe
State/province [2] 5106 0
Beitbridge/South Matabeleland
Country [3] 5107 0
Zimbabwe
State/province [3] 5107 0
Uzumba Maramba Pfungwe/East Mashonaland
Country [4] 5108 0
Zimbabwe
State/province [4] 5108 0
Mt Darwin/ Central Mashonaland
Country [5] 5109 0
Zimbabwe
State/province [5] 5109 0
Mutasa/Manicaland
Country [6] 5110 0
Zimbabwe
State/province [6] 5110 0
Kariba/West Mashonaland
Country [7] 5111 0
Zimbabwe
State/province [7] 5111 0
Chirrdzi/ Masvingo
Country [8] 5112 0
Zimbabwe
State/province [8] 5112 0
Binga/North Matabeleland

Funding & Sponsors
Funding source category [1] 287353 0
Government body
Name [1] 287353 0
Ministry of Health and Child Welfare
Country [1] 287353 0
Zimbabwe
Primary sponsor type
Government body
Name
Ministry of Health and Child Welfare
Address
Kaguvi Building, 4th Floor
Central Avenue (Between 4th and 5th Street)
P.O. Box CY1122
Causeway
Harare
Country
Zimbabwe
Secondary sponsor category [1] 286100 0
None
Name [1] 286100 0
Address [1] 286100 0
Country [1] 286100 0
Other collaborator category [1] 277434 0
Other
Name [1] 277434 0
World Health Organisation
Address [1] 277434 0
20 Ave Appia
1211 Geneva 27
Country [1] 277434 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289328 0
WHO Ethics Review Committee
Ethics committee address [1] 289328 0
20 Ave Appia
1211 Geneva 27
Ethics committee country [1] 289328 0
Switzerland
Date submitted for ethics approval [1] 289328 0
14/03/2013
Approval date [1] 289328 0
14/05/2013
Ethics approval number [1] 289328 0
RPC568

Summary
Brief summary
This is a surveillance study to monitor the safety and efficacy of the fixed combination of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in children and adults. Patients will be recruited from 8 sentinel sites located in 8 malarious provinces of Zimbabwe. The primary outcome is the proportion of patients with PCR-adjusted adequate clinical and parasitological response accroding to WHO protocol (2009).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40258 0
Dr Susan Lily Mutambu
Address 40258 0
Ministry of Health and Child Welfare
Box CY 1122
Causeway
Harare
Country 40258 0
Zimbabwe
Phone 40258 0
+263 773 786602
Fax 40258 0
Email 40258 0
[email protected]
Contact person for public queries
Name 40259 0
Dr Susan Lily Mutambu
Address 40259 0
Ministry of Health and Child Welfare
Box CY 1122
Causeway
Harare
Country 40259 0
Zimbabwe
Phone 40259 0
+263 773 786602
Fax 40259 0
Email 40259 0
[email protected]
Contact person for scientific queries
Name 40260 0
Dr Susan Lily Mutambu
Address 40260 0
Ministry of Health and Child Welfare
Box CY 1122
Causeway
Harare
Country 40260 0
Zimbabwe
Phone 40260 0
+263 773 786602
Fax 40260 0
Email 40260 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.