Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001009909
Ethics application status
Approved
Date submitted
19/09/2011
Date registered
20/09/2011
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate+ sulfadoxine/ pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in Jamame (Lower Jubba region), Janaale (Lower Shabelle region) and Jowhar (Middle Shabelle region), Somalia
Scientific title
Efficacy and safety of artesunate+ sulfadoxine/ pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in Jamame (Lower Jubba region), Janaale (Lower Shabelle region) and Jowhar (Middle Shabelle region), Somalia
Secondary ID [1] 262775 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 270482 0
Condition category
Condition code
Infection 270639 270639 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm propective evaluation with artesunate+sulfadoxine+ pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria. Eligible subjects will be treated with artesunate+sulfadoxine+pyrimethamine. All patients will be followed up for 28 days.

Dose regimen:
artesunate+sulfadoxine/pyrimethamine tablets: artesunate 4 mg/kg body weight per day for 3 days plus a single dose of 25/1.25 mg/kg body weight of sulfadoxine+pyrimethamine.
All treatment will be orally taken tablets.
Intervention code [1] 267116 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] 269367 0
% of artesunate+sulfadoxine+pyrimethamine 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 (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).
Timepoint [1] 269367 0
Timepoint: At 28 day following treatment
Secondary outcome [1] 279458 0
% of adverse events (e.g. abdominal pain, nausea, vomiting, headache and dizziness) in the artesunate+sulfadoxine/ pyrimethamine 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 [1] 279458 0
Timepoint: At 28 day following treatment

Eligibility
Key inclusion criteria
*age between 6 months and 60 years with the exception of 12-18 years old female minors and unmarried females above 18 years;
*mono-infection with P. falciparum detected by microscopy;
*parasitaemia of 500 - 200,000/microlitre asexual forms;
*presence of axillary temperature greater or equal to 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
6 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 < 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); and
*a positive pregnancy test or breastfeeding;
*Unable to or unwilling to take a pregnancy test or 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 treatment doses 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)
N/A. 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
Completed
Date of first participant enrolment
Anticipated
29/07/2011
Actual
25/07/2011
Date of last participant enrolment
Anticipated
Actual
5/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment outside Australia
Country [1] 3767 0
Somalia
State/province [1] 3767 0
Lower Juba, Lower Shabelle and Middle Shabelle
Country [2] 5969 0
Somalia
State/province [2] 5969 0
Lower Shabelle
Country [3] 5970 0
Somalia
State/province [3] 5970 0
Middle Shabelle

Funding & Sponsors
Funding source category [1] 269596 0
Government body
Name [1] 269596 0
Ministry of Health
Country [1] 269596 0
Somalia
Primary sponsor type
Government body
Name
Ministry of Health
Address
1 Villa Somalia
Mogadishu,
Democratic Republic of Somalia 25252
Country
Somalia
Secondary sponsor category [1] 266628 0
None
Name [1] 266628 0
Address [1] 266628 0
Country [1] 266628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269547 0
Ministry of Health
Ethics committee address [1] 269547 0
1 Villa Somalia
Mogadishu,
Democratic Republic of Somalia 25252
Ethics committee country [1] 269547 0
Somalia
Date submitted for ethics approval [1] 269547 0
Approval date [1] 269547 0
22/06/2011
Ethics approval number [1] 269547 0
MOH &HS/MO/356/2011
Ethics committee name [2] 269548 0
World Health Organization Ethical Review Committee (WHO ERC)
Ethics committee address [2] 269548 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [2] 269548 0
Switzerland
Date submitted for ethics approval [2] 269548 0
Approval date [2] 269548 0
25/07/2011
Ethics approval number [2] 269548 0
RPC473

Summary
Brief summary
Title: Efficacy and safety of artesunate+sulfadoxine/ pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in Jamame (Lower Jubba region), Janaale (Lower Shabelle region) and Jowhar (Middle Shabelle region), Somalia.

Background: Therapeutic efficacy studies will be done in Somalia to assess the efficacy and safety of artesunate+ sulfadoxine/pyrimethamine for the treatment of uncomplicated falciparum malaria. The participants will be febrile people aged between 6 months and 60 years except female minors aged 12-18 and umarreied women. Patients will be treated with artesunate+sulfadoxine/pyrimethamine once a day over 3 consecutive 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 of Somalia in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Trial website
Trial related presentations / publications
There is no trial related presentations/publications
Public notes

Contacts
Principal investigator
Name 32973 0
Mr Abdullahi Mohamed Hassan
Address 32973 0
WHO Representative for Somalia Warwick Centre, Gigiri, United Nations Avenue, Nairobi Kenya Postal Address: P.O.Box 63565 Nairobi Kenya
Country 32973 0
Somalia
Phone 32973 0
+252615500514
Fax 32973 0
Email 32973 0
[email protected]
Contact person for public queries
Name 16220 0
Mr Mr Abdullahi Mohamed Hassan
Address 16220 0
WHO Representative for Somalia
Warwick Centre, Gigiri, United Nations Avenue, Nairobi Kenya
Postal Address: P.O.Box 63565 Nairobi Kenya
Country 16220 0
Somalia
Phone 16220 0
+252 6 15500514
Fax 16220 0
Email 16220 0
[email protected]
Contact person for scientific queries
Name 7148 0
Mr Mr Abdullahi Mohamed Hassan
Address 7148 0
C/O WHO Representative for Somalia
Warwick Centre, Gigiri, United Nations Avenue, Nairobi Kenya
Postal Address: P.O.Box 63565 Nairobi Kenya
Country 7148 0
Somalia
Phone 7148 0
+252 6 15500514
Fax 7148 0
Email 7148 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.