Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000940875
Ethics application status
Approved
Date submitted
3/09/2012
Date registered
4/09/2012
Date last updated
4/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Brazzaville and Owando - Republic of the Congo
Scientific title
Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Brazzaville and Owando - Republic of the Congo
Secondary ID [1] 281131 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287300 0
Condition category
Condition code
Infection 287631 287631 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the efficacy and safety of artesunate/amodiaquine (4 mg/kg of artesunate, 10 mg/kg of amodiaquine, 1/day for 3 days) (oral administration) for the treatment of uncomplicated P. falciparum infections in two sites in the Republic of Congo
Intervention code [1] 285589 0
Treatment: Drugs
Comparator / control treatment
To assess the efficacy and safety of artemether/lumefantrine
(20 mg of artemether and 120 mg of lumefantrine), 2/day for 3 days) (oral administration) for the treatment of uncomplicated P. falciparum infections in two sites in the Republic of Congo
Control group
Active

Outcomes
Primary outcome [1] 287882 0
Percent of treatment failures (early treatment failure + late clinical failure + late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.
Timepoint [1] 287882 0
At day 28 following initiation of treatment
Secondary outcome [1] 298977 0
Percent of adverse event will be documented. Parents or guardians of all enrolled patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form.

Possible medicine related adverse effects include dizziness, itching, vomiting, abdominal pain, flatulence, headache, bodyache, diarrhoea, tinnitus and increased hair loss, macular rash, reduction in neutrophil counts and convulsions. However, it is likely that many of these effects are disease-related rather than medicine-induced.
Timepoint [1] 298977 0
At day 28 following initiation of treatment.

Eligibility
Key inclusion criteria
1. age between 6 months and 10 yeasr;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000-200,000/microlitre asexual forms;
4. presence of axillary (greater or equal to) 37.5 degrees C or history of fever during the past 24 h;
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; and
7. informed consent from a parent or guardian of children.
Minimum age
6 Months
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
2. mixed or mono-infection with another Plasmodium species detected by microscopy;
3. presence of severe malnutrition (defined as a child whose growth standard is below –3 (z-score), having a symmetrical oedema involving at least the feet or having a mid-upper arm circumference < 110 mm);
4. 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 (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
5. regular medication, which may interfere with antimalarial pharmacokinetics;
6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children aged 6 months to 10 years with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with either artesunate/amodiaquine or artemether/lumefantrine and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A This surveillance study is 2 x one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria with either artesunate/amodiaquine or artemether/lumefantrine.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
352
Accrual to date
Final
Recruitment outside Australia
Country [1] 4519 0
Congo
State/province [1] 4519 0

Funding & Sponsors
Funding source category [1] 285913 0
Other Collaborative groups
Name [1] 285913 0
World Health Organization
Country [1] 285913 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health and Population of the Republic of Congo
Address
Ministere de la Sante et de la Population de la Republique du Congo
Enceint ex ORSTOM, BP 1249
Brazzaville - Congo
Country
Congo
Secondary sponsor category [1] 284734 0
University
Name [1] 284734 0
Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna
Address [1] 284734 0
Kinderspitalgasse 15, A-1090
Vienna
Country [1] 284734 0
Austria

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287941 0
Ministere de la Recherche Scientifique
Ethics committee address [1] 287941 0
Delegation Generale de la Recherche Scientifique et Technologique
Comite d'Ethique de la Recherche en Sciences de la Sante
B.P. 2499, BRAZZAVILLE, CONGO
Ethics committee country [1] 287941 0
Congo
Date submitted for ethics approval [1] 287941 0
20/04/2012
Approval date [1] 287941 0
03/05/2012
Ethics approval number [1] 287941 0
00000039/DGRST/CERSSA
Ethics committee name [2] 287942 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 287942 0
Avenune Appia 20
1211 Geneva 27
Ethics committee country [2] 287942 0
Switzerland
Date submitted for ethics approval [2] 287942 0
18/06/2012
Approval date [2] 287942 0
17/07/2012
Ethics approval number [2] 287942 0
RPC509

Summary
Brief summary
Efficacy and safety of artesunate/amodiaquine and artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in two sites in the Congo
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34646 0
Address 34646 0
Country 34646 0
Phone 34646 0
Fax 34646 0
Email 34646 0
Contact person for public queries
Name 17893 0
Dr Mathieu Ndounga
Address 17893 0
Charge de Recherche Cames
Centre d'Etudes sur les Ressources Vegetales
Groupe de Recherche Biomedicale
Enceinte ex ORSTOM, BP 1249
Brazzaville - Congo
Country 17893 0
Congo
Phone 17893 0
242066977370
Fax 17893 0
Email 17893 0
[email protected]
Contact person for scientific queries
Name 8821 0
Dr Mathieu Ndounga
Address 8821 0
Charge de Recherche Cames
Centre d'Etudes sur les Ressources Vegetales
Groupe de Recherche Biomedicale
Enceinte ex ORSTOM, BP 1249
Brazzaville - Congo
Country 8821 0
Congo
Phone 8821 0
242066977370
Fax 8821 0
Email 8821 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
SourceTitleYear of PublicationDOI
Dimensions AIMalaria burden and anti-malarial drug efficacy in Owando, northern Congo2016https://doi.org/10.1186/s12936-015-1078-4
N.B. These documents automatically identified may not have been verified by the study sponsor.