Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000945729
Ethics application status
Approved
Date submitted
19/08/2013
Date registered
27/08/2013
Date last updated
27/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of Artesunate plus Sulfadoxine /Pyrimethamine and Artemether-Lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kassala (Kassala State), Kosti (White Nile State), Sinnar (Sinnar State), Damazin (Blue Nile State), and Gadaref (Gadaraf State), Sudan
Scientific title
Assessment of the therapeutic efficacy, in terms of proportion of patients with PCR-corrected adequate clinical and parasitological response of the combination of artesunate plus sulfadoxine-pyrimethamine and that of the fixed combination of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in patients over 6 months of age recruited from Kassala, Kosti, Sinnar, Damazin, and Gadaref, Sudan
Secondary ID [1] 283030 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
uncomplicated falciparum malaria 289862 0
Condition category
Condition code
Infection 290223 290223 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum malaria. In five study sites eligible patients will be treated with artesunate at a dose of 4 mg per kg plus a fixed combination of sulfadoxine at a dose of 25 mg per kg and pyrimethamine at a dose of 1.25 mg per kg on the first day, then 4 mg per kg ofartesunate on the two following days. Patients will receive tablets containing 50 mg of artesunate and tablet containing 500 mg of sulfadoxine plus 25 mg of pyrimethamine. The number of tablets to be administered is determined according to body weight. In three other sites eligible patients will be administered fixed combination tablet, each containing 20 mg of artemether and 120 mg of lumefantrine, twice a day for three consecutive days. The number of tablets to be administered twice daily 8 hours apart is determined according to body weight: 5-14 kg, 1 tab; 15-24 kg, 2 tab; 25- 34 kg 3 tab; over 35kg 4 tab. Patients will be seen for clinical and parasitological evaluation, daily for the first 3 days, then weekly until day 28, or at any time if malaria syptoms re-occurred.
Intervention code [1] 287757 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290254 0
Proportion of patients with adequate clinical and parasitological response adjusted by polymerase chain reaction (PCR)
Timepoint [1] 290254 0
Day 28
Secondary outcome [1] 304214 0
Nature and incidence of adverse events. Possible adverse events are those known to occur with antimalarials, and include headache, body ache, nausea, vomiting, abdominal discomfort, liver enzyme elevation, and dizziness.
Timepoint [1] 304214 0
Day 28

Eligibility
Key inclusion criteria
Age above six months excluding female minors aged 12-17 years inclusive and unmarried women above 17 years;
Mono-infection with P. falciparum detected by microscopy;
Parasitaemia of 1000-100,00 per microlieter asexual forms;
Presence of axillary temperature equal or greater 37.5 degrees Celsius, 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
No limit
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 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 less than 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, HIV/AIDS);
Regular medication, which may interfere with antimalarial pharmacokinetics;
History of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments; and
A positive pregnancy test or breastfeeding.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/09/2013
Actual
Date of last participant enrolment
Anticipated
9/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
704
Accrual to date
Final
Recruitment outside Australia
Country [1] 5310 0
Sudan
State/province [1] 5310 0
Kassala
Country [2] 5311 0
Sudan
State/province [2] 5311 0
White Nile
Country [3] 5312 0
Sudan
State/province [3] 5312 0
Sinnar
Country [4] 5313 0
Sudan
State/province [4] 5313 0
Blue Nile
Country [5] 5314 0
Sudan
State/province [5] 5314 0
Gadaref

Funding & Sponsors
Funding source category [1] 287799 0
Government body
Name [1] 287799 0
Republic of Sudan Federal Ministry of Health
Country [1] 287799 0
Sudan
Funding source category [2] 287800 0
Other
Name [2] 287800 0
World Health Organisation
Country [2] 287800 0
Switzerland
Primary sponsor type
Government body
Name
Republic of Sudan Federal Ministry of Health
Address
Algamaa Street
P.O.Box 1204
Khartoum
Country
Sudan
Secondary sponsor category [1] 286529 0
None
Name [1] 286529 0
Address [1] 286529 0
Country [1] 286529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289747 0
World Health Organisation Ethics Review Committee
Ethics committee address [1] 289747 0
Avenue Appia 20
1211 Geneva
Ethics committee country [1] 289747 0
Switzerland
Date submitted for ethics approval [1] 289747 0
Approval date [1] 289747 0
14/08/2013
Ethics approval number [1] 289747 0
RPC584

Summary
Brief summary
An antimalarial drug efficacy trial will be conducted in Kassala (Kassala State), Kosti (White Nile state), Sinnar (Sinnar State), Damazin (Blue Nile State), Sudan. The participants will be febrile people above six month of age, excluding female minors aged 12-17 years inclusive and unmarried women above 17 years, with confirmed uncomplicated P. falciparum infection. Patients will be treated with Artesunate plus Sulfadoxine-pyrimethamine tablet, (4mg/kg of artesunate)+(25mg/kg sulfadoxine plus1.25mg/kg pyrimethamine) on the first day then 4mg/kg Artesunate on the following two days, or Artemether (20mg)/Lumefantrine (120mg) tablet, six-dose course over 3 days (2 doses daily) according to body weight. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from September 2013 to March 2014. 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 malaria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42202 0
Dr Khalid Elmardi
Address 42202 0
Republic of Sudan Federal Ministry of Health
National Malaria Control Programme
Algamaa Street
P.O. Box 1204
Khartoum
Country 42202 0
Sudan
Phone 42202 0
+249912817230
Fax 42202 0
Email 42202 0
[email protected]
Contact person for public queries
Name 42203 0
Dr Khalid Elmardi
Address 42203 0
Republic of Sudan Federal Ministry of Health
National Malaria Control Programme
Algamaa Street
P.O. Box 1204
Khartoum
Country 42203 0
Sudan
Phone 42203 0
+249912817230
Fax 42203 0
Email 42203 0
[email protected]
Contact person for scientific queries
Name 42204 0
Dr Khalid Elmardi
Address 42204 0
Republic of Sudan Federal Ministry of Health
National Malaria Control Programme
Algamaa Street
P.O. Box 1204
Khartoum
Country 42204 0
Sudan
Phone 42204 0
+249912817230
Fax 42204 0
Email 42204 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 artemether-lumefantrine and declining efficacy of artesunate + sulfadoxine-pyrimethamine against Plasmodium falciparum in Sudan (2010-2015): Evidence from in vivo and molecular marker studies.2016https://dx.doi.org/10.1186/s12936-016-1339-x
N.B. These documents automatically identified may not have been verified by the study sponsor.