Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001244998
Ethics application status
Approved
Date submitted
30/11/2011
Date registered
6/12/2011
Date last updated
5/03/2018
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 four sites of Pakistan
Scientific title
Efficacy and safety of artesunate+sulfadoxine/pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in four sites of Pakistan
Secondary ID [1] 273506 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 279306 0
Condition category
Condition code
Infection 279498 279498 0 0
Studies of infection and infectious agents

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 sulfadoxine 25/1.25 pyrimethamine mg/kg body weight.
All treatment will be orally taken tablets.
Intervention code [1] 283822 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] 286061 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] 286061 0
At 28 day following treatment
Secondary outcome [1] 295061 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] 295061 0
At 28 day following treatment

Eligibility
Key inclusion criteria
*age between 6 months and 60 years with the exception of 12-17 years old female minors and unmarried females aged 18 years and above;
*mono-infection with P. falciparum detected by microscopy;
*parasitaemia of 1000 – 250000 / micro liter asexual forms for sites in Sindh, Baluchistan and FATA and parasitaemia of 250 – 250000 / microliterl asexual forms for the site in Punjab;
*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
1/01/2012
Actual
12/01/2011
Date of last participant enrolment
Anticipated
Actual
20/12/2012
Date of last data collection
Anticipated
Actual
19/01/2013
Sample size
Target
340
Accrual to date
Final
314
Recruitment outside Australia
Country [1] 3987 0
Pakistan
State/province [1] 3987 0

Funding & Sponsors
Funding source category [1] 284295 0
University
Name [1] 284295 0
Liaqat University of Medicine and Health Sciences
Country [1] 284295 0
Pakistan
Primary sponsor type
University
Name
Liaqat University of Medicine and Health Sciences
Address
Jamshoro, Sindh - Pakistan.
Country
Pakistan
Secondary sponsor category [1] 283245 0
None
Name [1] 283245 0
Address [1] 283245 0
Country [1] 283245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286257 0
Health Services Academy, Ministry of Inter Provincial Coordination
Ethics committee address [1] 286257 0
Park Road, Chak Shahzad,
Islamabad,
Pakistan
Ethics committee country [1] 286257 0
Pakistan
Date submitted for ethics approval [1] 286257 0
01/07/2011
Approval date [1] 286257 0
12/09/2011
Ethics approval number [1] 286257 0
Letter of approval. No number

Summary
Brief summary
Title: Efficacy and safety of artesunate+sulfadoxine/pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in four sites of Pakistan.

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 12-17 and umarreied women aged 18 years and above. Patients will be treated with tesunate+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 Pakistan in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33469 0
Mr Munir Ahmad Khan
Address 33469 0
Provincial Reference Laboratory ,
Institute of Public Health,
Quetta Balochistan
Country 33469 0
Pakistan
Phone 33469 0
+92 3337807644
Fax 33469 0
Email 33469 0
[email protected]
Contact person for public queries
Name 16716 0
Dr Dr Salma Shaikh
Address 16716 0
Liaqat University of Medical and Health Sciences,
Jamshoro, Sindh, Pakistan
Country 16716 0
Pakistan
Phone 16716 0
+92-22-2785115
Fax 16716 0
+92-22-2784012
Email 16716 0
[email protected]
Contact person for scientific queries
Name 7644 0
Dr Dr Marian Warsame
Address 7644 0
Global malaria Programme
World Health Organization
20 Av. Appia,
1211 Geneva 27 Switzerland
Country 7644 0
Switzerland
Phone 7644 0
+41 22 791 5076
Fax 7644 0
+41 22 791 48 24
Email 7644 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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