Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000696099
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
24/08/2010
Date last updated
3/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in At Tur Bani Qa'is, Harad, Almusaymir, Jabal Ash Sharq, Al Udayn and Bajil districts in Yemen
Scientific title
Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Yemen
Secondary ID [1] 251806 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 257402 0
Condition category
Condition code
Infection 257550 257550 0 0
Studies of infection and infectious agents
Public Health 257551 257551 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-arm propective evaluation with:
(a) artesunate+sulfadoxine/pyrimethamine combination therapy in 4 sites (Al Tor beni Qais, Harad, Almosaimeer, Al Odein) and
(b) artemether-lumefantrine combination therapy in two sites (Jabal Al Sharq and Bajil).

Dose regimen:
(a) artesunate+sulfadoxine/pyrimethamine tablets: artesunate 4 mg/kg body weight (bw) per day for 3 days plus a single dose of 25/1.25 mg/kg bw of sulfadoxine/ pyrimethamine.

(b) artemether-lumefantrine tablets (tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrine twice a day for 3 days according to the following weigth bands:
5-14 kg bw: 1 tablet; 15-24 kg bw: 2 tablets; 25-34 kg bw: 3 tablets and =35 kg bw: 4 tablets.

All treatment will be orally taken tablets
Intervention code [1] 256508 0
Treatment: Drugs
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258459 0
% of artesunate+sulfadoxine/pyrimethamine treatment failure (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] 258459 0
At 28 day following treatment
Primary outcome [2] 258460 0
% of artemether-lumefantrine treatment failure (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 [2] 258460 0
At 28 day following treatment
Primary outcome [3] 259021 0
% of adverse events in the artesunate+sulfadoxine/ pyrimethamine and artemether-lumefantrine treated groups.


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 [3] 259021 0
At 28 day following treatment
Secondary outcome [1] 265257 0
Nil
Timepoint [1] 265257 0
Nil

Eligibility
Key inclusion criteria
1. age 6 months and above;
2. mono-infection with Plasmodium falciparum (P.falciparum) detected by microscopy;
3. parasitaemia of 500-200000/microliter asexual forms;
4. presence of axillary temperature less than or equal to 37.5 degrees centigrade;
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 World Health Organization (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 <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, Human immunodeficiency virus/Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (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);
7. unmarried women of child-bearing age;
8. a positive pregnancy test or breastfeeding;
9. unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
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
1/11/2009
Actual
8/11/2009
Date of last participant enrolment
Anticipated
Actual
3/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
522
Accrual to date
Final
Recruitment outside Australia
Country [1] 2639 0
Yemen
State/province [1] 2639 0
Hajja Governorate
Country [2] 2640 0
Yemen
State/province [2] 2640 0
Al-Hudeida Governorate
Country [3] 2641 0
Yemen
State/province [3] 2641 0
Ibb Governorate
Country [4] 2642 0
Yemen
State/province [4] 2642 0
Dhamar Governorate
Country [5] 2643 0
Yemen
State/province [5] 2643 0
Lahj Governorate

Funding & Sponsors
Funding source category [1] 256995 0
Government body
Name [1] 256995 0
Ministry of Public Health and population
Country [1] 256995 0
Yemen
Primary sponsor type
Government body
Name
Ministry of Public Health and Population
Address
P.O. Box: 16544, Sana'a
Country
Yemen
Secondary sponsor category [1] 256258 0
None
Name [1] 256258 0
None
Address [1] 256258 0
None
Country [1] 256258 0
Other collaborator category [1] 1269 0
Other Collaborative groups
Name [1] 1269 0
World Health organization
Address [1] 1269 0
20 Av. Appia, 1211 Geneva 27 Switzerland
Country [1] 1269 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259007 0
General Doctorate for Research and Studies
Ethics committee address [1] 259007 0
P.O. Box: 16544, Sana'a
Ethics committee country [1] 259007 0
Yemen
Date submitted for ethics approval [1] 259007 0
Approval date [1] 259007 0
12/10/2009
Ethics approval number [1] 259007 0
64
Ethics committee name [2] 259008 0
WHO Ethical Review Committee (ERC)
Ethics committee address [2] 259008 0
20 Av. Appia,
1211 Geneva 27 Switzerland
Ethics committee country [2] 259008 0
Switzerland
Date submitted for ethics approval [2] 259008 0
11/12/2009
Approval date [2] 259008 0
21/01/2010
Ethics approval number [2] 259008 0
RPC372

Summary
Brief summary
The study assesses the efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in The participants will be febrile patients aged 6 months and above with confirmed uncomplicated P. falciparum infection. Artesunate (4mg/kg over 3 days) co-administered with sulfadoxine/pyrimethamine (single dose of 25mg sulfadoxine/1.25mg pyrimethamine per kg on day 0) will be tested in four of the sites and artemether-lumefantrine (a 6-dose regimen of artemether-lumefantrine twice a day for 3 days) in the other two sites. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from November 2009 to April 2010.
Trial website
Trial related presentations / publications
The data from the study was communicated to Ministry of health. No peer reviewed publication has been published yet.
Public notes

Contacts
Principal investigator
Name 31182 0
Dr Fathi Ali Mohammed Hizam
Address 31182 0
National Malaria Control Programme,
Ministry of Public Health & Population
PO Box: 16544, Sana'a, Yemen.
Sana'a
Yemen
Country 31182 0
Yemen
Phone 31182 0
+967 1626107
Fax 31182 0
Email 31182 0
[email protected]
Contact person for public queries
Name 14429 0
Dr Dr Mohamed Abdullah Al-Henemi
Address 14429 0
National Malaria Control Programme, P.O. Box: 16544, Sana'a
Country 14429 0
Yemen
Phone 14429 0
+9671626107
Fax 14429 0
Email 14429 0
[email protected]
Contact person for scientific queries
Name 5357 0
Dr Dr Fathi Ali Mohammed Hizam
Address 5357 0
National Malaria Control Programme, P.O. Box: 16544, Sana'a
Country 5357 0
Yemen
Phone 5357 0
+967 1626107
Fax 5357 0
Email 5357 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
EmbaseHigh efficacy of two artemisinin-based combinations: Artesunate + sulfadoxine-pyrimethamine and artemether-lumefantrine for falciparum malaria in Yemen.2015https://dx.doi.org/10.1186/s12936-015-0970-2
N.B. These documents automatically identified may not have been verified by the study sponsor.