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Trial registered on ANZCTR


Registration number
ACTRN12612001090808
Ethics application status
Approved
Date submitted
21/09/2012
Date registered
12/10/2012
Date last updated
12/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Monitoring the Efficacy of Artesunate+Sulfadoxine-Pyrimethamine and Artemether Plus Lumefantrine in Uncomplicated Falciparum Malaria in Pakistan
Scientific title
Monitoring the Efficacy of Artesunate+Sulfadoxine-Pyrimethamine and Artemether Plus Lumefantrine in Uncomplicated Falciparum Malaria in Pakistan
Secondary ID [1] 281279 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287482 0
Condition category
Condition code
Infection 287813 287813 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+sulfadoxine-pyrimethamine for the treatment of uncomplicated P. falciparum malaria in three sentinel sites in Pakistan. The daily dose of artesunate (4 mg/kg) over 3 days co-administered with a single dose of sulfadoxine/pyrimethamine (25 mg sulfadoxine/1.25 mg pyrimethamine per kg) on day 0 will be administered orally.
Intervention code [1] 285751 0
Treatment: Drugs
Comparator / control treatment
To assess the efficacy and safety of artemether-lumifantrine for the treatment of uncomplicated P. falciparum malaria in three sentinel sites in Pakistan. An oral dose of artemether-lumefantrine (a tablet containing artemether 20 mg plus lumefantrine 120 mg): six-dose course over 3 days (2 doses daily) according to weight bands (1 tab: 5-14kg, 2 tabs: 15-24kg, 3 tabs: 25-34kg and 4tabs: greater than 35kg).
Control group
Active

Outcomes
Primary outcome [1] 288036 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] 288036 0
At day 28 following initiation of treatment
Secondary outcome [1] 299317 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] 299317 0
At day 28 following initiation of treatment

Eligibility
Key inclusion criteria
1. Age greater than 6 months, excluding 12-17 old female minors and unmarried females aged 18 years and above;
2. mono-infection with P. falciparum detected by microscopy;
3. Parasitaemia of 1000 – 250000 / microlitre asexual forms for sites in Sindh, Balochistan and Khyber Pakhtoonkwa.
4. Presence of axillary temperature equal to or greater than 37.5 degrees celsius or history of fever during the past 48 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 the patient or from a parent or guardian in the case of children.
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of general danger signs in children aged under 5 years 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, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 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); and
7. 12-17 old female minors and unmarried females aged 18 years and above;

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)
People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with artesunate+sulfadoxine/ pyrimethamine or Artemether plus Lumifantrin, 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. Patients will be treated with artesunate+sulphadoxine /pyrimethamine in two sites (Women and Children Hospital Bannu in Khyber Pakhtoonkwa and DHQ Hospital Zhob) or with artemether-lumefantrine will be evaluated in two sites (University Hospital Jamshoro Hyderabad and DHQ Zhob).
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
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 4567 0
Pakistan
State/province [1] 4567 0

Funding & Sponsors
Funding source category [1] 286046 0
Other Collaborative groups
Name [1] 286046 0
World Health Organization
Country [1] 286046 0
Switzerland
Primary sponsor type
University
Name
Bannu Medical College
Address
Bannu City,
Khyber Pakhtoonkhwa Province
Country
Pakistan
Secondary sponsor category [1] 284859 0
None
Name [1] 284859 0
Address [1] 284859 0
Country [1] 284859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288095 0
National Bioethics Committee (NBC) Pakistan
Ethics committee address [1] 288095 0
Ethics committee country [1] 288095 0
Pakistan
Date submitted for ethics approval [1] 288095 0
11/06/2012
Approval date [1] 288095 0
07/09/2012
Ethics approval number [1] 288095 0
4-87/12/NBC-101/RDC/863
Ethics committee name [2] 288096 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 288096 0
Ethics committee country [2] 288096 0
Switzerland
Date submitted for ethics approval [2] 288096 0
07/08/2012
Approval date [2] 288096 0
17/08/2012
Ethics approval number [2] 288096 0
RCP535

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34745 0
Address 34745 0
Country 34745 0
Phone 34745 0
Fax 34745 0
Email 34745 0
Contact person for public queries
Name 17992 0
Professor Shuaib Khan
Address 17992 0
Bannu Medical College
Bannu City
Khyber Pakhtoonkhwa
Country 17992 0
Pakistan
Phone 17992 0
+92 862 4305
Fax 17992 0
Email 17992 0
mshoaibkhan2003@yahoo.com
Contact person for scientific queries
Name 8920 0
Professor Shuaib Khan
Address 8920 0
Bannu Medical College
Bannu City
Khyber Pakhtoonkhwa
Country 8920 0
Pakistan
Phone 8920 0
+92 862 4305
Fax 8920 0
Email 8920 0
mshoaibkhan2003@yahoo.com

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.