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Trial registered on ANZCTR


Registration number
ACTRN12611001253998
Ethics application status
Approved
Date submitted
3/12/2011
Date registered
7/12/2011
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 Kassala (Kassala State), Kosti (White Nile state), Sinnar (Sinnar State), Damazin (Blue Nile State), Sudan
Scientific title
Efficacy and safety of artesunate+sulfadoxine/pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in Kassala (Kassala State), Kosti (White Nile state), Sinnar (Sinnar State), Damazin (Blue Nile State), Sudan
Secondary ID [1] 273526 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 279326 0
Condition category
Condition code
Infection 279512 279512 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/pyrimethamine 1.25 mg/kg body weight.
All treatment will be orally taken tablets.
Intervention code [1] 283839 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] 286080 0
Primary outcome: % 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] 286080 0
At 28 day following treatment
Secondary outcome [1] 295088 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] 295088 0
At 28 day following treatment

Eligibility
Key inclusion criteria
*age above 6 months 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 – 100000 /micro liter 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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9648 0
Sudan
State/province [1] 9648 0
Gadaref, Kosit, Sennar and Kassala states

Funding & Sponsors
Funding source category [1] 284315 0
Government body
Name [1] 284315 0
Federal Ministry of Health of Sudan
Address [1] 284315 0
National Malaria control programme
P.O. Box 1204
Khartoum, SUDAN
Country [1] 284315 0
Sudan
Primary sponsor type
Government body
Name
Federal Ministry of Health of Sudan
Address
National Malaria control programme
P.O. Box 1204
Khartoum, SUDAN
Country
Sudan
Secondary sponsor category [1] 283259 0
None
Name [1] 283259 0
Address [1] 283259 0
Country [1] 283259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286278 0
National Research Ethics Review Committee
Ethics committee address [1] 286278 0
Federal Ministry of Health
P.O.Box 303.
Khartoum - Sudan
Ethics committee country [1] 286278 0
Sudan
Date submitted for ethics approval [1] 286278 0
Approval date [1] 286278 0
22/08/2011
Ethics approval number [1] 286278 0
Ethical Clearance Certificate/22/08/2011
Ethics committee name [2] 286279 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 286279 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [2] 286279 0
Switzerland
Date submitted for ethics approval [2] 286279 0
11/10/2011
Approval date [2] 286279 0
25/10/2011
Ethics approval number [2] 286279 0
RPC486

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.

Methods: 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 Sudan in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33480 0
Dr Khalid Elmardi
Address 33480 0
Director General National Malaria Control Programme
Federal Ministry of Health
P.O. Box 1204 Khartoum, SUDAN

Country 33480 0
Sudan
Phone 33480 0
+249 155 155 590/92
Fax 33480 0
Email 33480 0
khalidmrd9@hotmail.com
Contact person for public queries
Name 16727 0
Dr Dr. Khalid Elmardi
Address 16727 0
Director General
National Malaria Control Programme
Federal Ministry of Health
P.O. Box 1204 Khartoum, SUDAN
Country 16727 0
Sudan
Phone 16727 0
+249 155 155 590/92
Fax 16727 0
+249 155 775 590
Email 16727 0
khalidmrd9@hotmail.com
Contact person for scientific queries
Name 7655 0
Dr Dr. Khalid Elmardi
Address 7655 0
Director General
National Malaria Control Programme
Federal Ministry of Health
P.O. Box 1204 Khartoum, SUDAN
Country 7655 0
Sudan
Phone 7655 0
+249 155 155 590/92
Fax 7655 0
+249 155 775 590
Email 7655 0
khalidmrd9@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary