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Trial registered on ANZCTR


Registration number
ACTRN12612000938808
Ethics application status
Approved
Date submitted
28/08/2012
Date registered
4/09/2012
Date last updated
6/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in South Sudan
Scientific title
Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in South Sudan
Secondary ID [1] 281112 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287273 0
Condition category
Condition code
Infection 287599 287599 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/amodiaquine (standard dose of 30mg/kg of amodiaquine (10mg/kg x 3 times per day for 3 days) and 12mg/kg of artesunate (4mg/kg x 3 times per day for 3 days) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally. Eligibile subjects will be treated for three days and followed up for 28 days.
Intervention code [1] 285566 0
Treatment: Drugs
Comparator / control treatment
Artemether/lumefantrine (20mg artemether and 120mg lumefantrine tablet) twice daily for three consecutive days for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally. Eligibile subjects will be treated for three days and followed up for 28 days.
Control group
Active

Outcomes
Primary outcome [1] 287859 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] 287859 0
At day 28 following initiation of treatment
Secondary outcome [1] 298952 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.

A patient can be discontinued from the study if the principal investigator decides so due to an adverse event of adequate nature or intensity. In this case, information on the adverse event and symptomatic treatment given must be recorded on a case report form. If the adverse event is serious, the principal investigator must notify the sponsor or its designee immediately and follow the reporting procedure as indicated in the Protocol.

The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy.

Adverse events requiring treatment can be treated according to local practice. If there is a clinical indication for any additional medication during the course of the study, including medication given to treat an adverse event related to the study medicine, the name of the medicine, the dosage and the date and time of administration must be recorded on the case report form.
Timepoint [1] 298952 0
At day 28 following initiation of treatment.

Eligibility
Key inclusion criteria
1. age between 6 to 59 months;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000-200,000/microlitre asexual forms;
4. presence of axillary (greater or equal to) 37.5 degrees C or history of fever during the past 24 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 of children.
Minimum age
6 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1) in children (aged 6- 59 months);
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, 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).

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)
Children aged 5-59 months with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with either artesunate/amodiaquine or artemether/lumefantrine and 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.
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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study was cancelled due to civil unrest
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment outside Australia
Country [1] 4513 0
Sudan
State/province [1] 4513 0

Funding & Sponsors
Funding source category [1] 285894 0
Charities/Societies/Foundations
Name [1] 285894 0
The Global Fund to fight AIDS, Tuberculosis and Malaria
Country [1] 285894 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health of the Republic of South Sudan
Address
Directorate of Research, Monitoring and Evaluation
Headquarters
Ministry of Health the Republic of South Sudan
Juba
Republic of South Sudan
Country
Sudan
Secondary sponsor category [1] 284717 0
Other Collaborative groups
Name [1] 284717 0
World Health Organization
Address [1] 284717 0
Avenue Appia 20
1202 Geneva
Switzerland
Country [1] 284717 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287922 0
Ministry of Health, Republic of South Sudan
Ethics committee address [1] 287922 0
Ethics committee country [1] 287922 0
Sudan
Date submitted for ethics approval [1] 287922 0
Approval date [1] 287922 0
11/04/2012
Ethics approval number [1] 287922 0
Ethical Clearance Research, Monitoring and Evalution 11/04/2012

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

Contacts
Principal investigator
Name 34631 0
Dr Margaret Betty Eyobo
Address 34631 0
Ministry of Health
PO Box PO Box 88
Juba
Country 34631 0
Sudan
Phone 34631 0
+249 912424849
Fax 34631 0
Email 34631 0
[email protected]
Contact person for public queries
Name 17878 0
Dr. Margaret Betty Eyobo
Address 17878 0
Juba
South Sudan
Country 17878 0
Sudan
Phone 17878 0
+249 912424849
Fax 17878 0
Email 17878 0
[email protected]
Contact person for scientific queries
Name 8806 0
Dr. Margaret Betty Eyobo
Address 8806 0
Juba
South Sudan
Country 8806 0
Sudan
Phone 8806 0
+249 912424849
Fax 8806 0
Email 8806 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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