Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000426987
Ethics application status
Approved
Date submitted
14/04/2011
Date registered
27/04/2011
Date last updated
1/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate + amodiaquine for the treatment of uncomplicated Plasmodium falciparum infection in the new epidemiological context of low malaria transmission in Zanzibar
Scientific title
Efficacy and safety of artesunate + amodiaquine for the treatment of uncomplicated Plasmodium falciparum infection in the new epidemiological context of low malaria transmission in Zanzibar
Secondary ID [1] 260009 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 265668 0
Condition category
Condition code
Infection 265802 265802 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm prospective evaluation with artesunate + amodiaquine given over 3 days for the treatment of uncomplicated Plasmodium falciparum malaria.

Dose regimen:
Oral tablets of artesunate 4 mg/kg + amodiaquine 10 mg/kg once daily for 3 consecutive days. Each dose administration will be observed and recorded.
Intervention code [1] 264427 0
Treatment: Drugs
Comparator / control treatment
"N/A - This is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria".
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266555 0
% of artesunate-amodiaquine treatment failures (early treatment failure+late clinical failure+late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).
Timepoint [1] 266555 0
At 28 day following treatment
Primary outcome [2] 266556 0
% of adverse events (e.g. weakness, headache, nausea, vomiting, abdominal pain, diarrhoea etc) in the artesunate-amodiaquine treated patients. All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the case report form.
Timepoint [2] 266556 0
At 28 day following treatment
Secondary outcome [1] 276025 0
Nil
Timepoint [1] 276025 0
Nil

Eligibility
Key inclusion criteria
*age equal to or more than 3 months;
*mono-infection with P. falciparum detected by microscopy.
*presence of P. falciparum malaria asexual parasitaemia (any level);
*presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 h;
*ability to swallow oral medication;
*ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
*informed consent from the patient or from a parent or guardian in the case of children.
Minimum age
3 Months
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization (WHO);
*mixed or mono-infection with another Plasmodium species detected by microscopy;
*presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm);
*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, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(HIV/AIDS);
*regular medication, which may interfere with antimalarial pharmacokinetics;
*history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
* a positive pregnancy test
* unable to or unwilling to take contraceptives

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)
Potential patients will be screened for inclusion/exclusion criteria. Once the patient meets all the enrolment criteria and a parent/guardian consented to participate in the study, the patient will be recruited in to the study. All antimalarial treatments will be given by a study team member under supervision. Thereafter, patients are required to undergo regular clinical reassessment. Blood films for parasite counts will be made on days 2, 3 and 7 and then weekly for the remainder of the follow-up period, i.e. on days 14, 21, and 28.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a one arm prospective study in which all eligible patients are given test drug.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 3389 0
Tanzania, United Republic Of
State/province [1] 3389 0
Zanzibar

Funding & Sponsors
Funding source category [1] 264902 0
Government body
Name [1] 264902 0
Ministry of Health and Social Welfare
Country [1] 264902 0
Tanzania, United Republic Of
Primary sponsor type
Government body
Name
Ministry of Health and Social Welfare, Zanzibar, Tanzania
Address
P.O. Box 236,
Zanzibar, Tanzania.
Country
Tanzania, United Republic Of
Secondary sponsor category [1] 264000 0
None
Name [1] 264000 0
Address [1] 264000 0
Country [1] 264000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266854 0
Zanzibar Research Health Ethics Committee
Ethics committee address [1] 266854 0
Ministry of Health and Social Welfare, P.O. Box 236, Zanzibar
Tanzania
Ethics committee country [1] 266854 0
Tanzania, United Republic Of
Date submitted for ethics approval [1] 266854 0
18/10/2010
Approval date [1] 266854 0
22/02/2011
Ethics approval number [1] 266854 0
ZAMREC 0002/November/010
Ethics committee name [2] 266857 0
World Health organization Ethical Research Committee (WHO ERC)
Ethics committee address [2] 266857 0
20, Avenue Appia
CH 1211 geneva 27
Ethics committee country [2] 266857 0
Switzerland
Date submitted for ethics approval [2] 266857 0
11/10/2010
Approval date [2] 266857 0
07/03/2011
Ethics approval number [2] 266857 0

Summary
Brief summary
Title: Efficacy and safety of artesunate + amodiaquine for the treatment of uncomplicated Plasmodium falciparum infection in the new epidemiological context of low malaria transmission in Zanzibar.

Background: Therapeutic efficacy studies will be done in Zanzibar to assess the efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated falciparum malaria. The study will be conducted in 20 primary health facilities of Zanzibar.

The participants will be febrile people equal to or above 6 months , inclusive. Patients will be treated with artesunate-amodiaquine daily for 3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The results of this study will be used to assist the Ministry of Health and Social Welfare, Tanzania, in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32496 0
Mr Mwinyi I. Msellem
Address 32496 0
Zanzibar Malaria Control Programme P.O.Box 503, Zanzibar, Tanzania
Country 32496 0
Tanzania, United Republic Of
Phone 32496 0
+255 77 743 29 11
Fax 32496 0
Email 32496 0
[email protected]
Contact person for public queries
Name 15743 0
Mr Mwinyi I. Msellem
Address 15743 0
Zanzibar Malaria Control Programme
P.O.Box 503,
Zanzibar, Tanzania
Country 15743 0
Tanzania, United Republic Of
Phone 15743 0
+255 77 743 29 11
Fax 15743 0
+255 24 223 18 76
Email 15743 0
[email protected]
Contact person for scientific queries
Name 6671 0
Mr Mwinyi I. Msellem
Address 6671 0
Zanzibar Malaria Control Programme
P.O.Box 503,
Zanzibar, Tanzania
Country 6671 0
Tanzania, United Republic Of
Phone 6671 0
+255 77 743 29 11
Fax 6671 0
+255 24 223 18 76
Email 6671 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

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