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Trial registered on ANZCTR


Registration number
ACTRN12614000765628
Ethics application status
Approved
Date submitted
11/06/2014
Date registered
17/07/2014
Date last updated
17/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine (AL) combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria in 4 sites in India Annuppur district, Madhya Pradesh, Jhabua district, Madhya Pradesh, Bastar district, Chhattisgarh and Palamudistrict, Jharkhand
Scientific title
A study evaluating the efficacy and safety of artemether lumefantrine for the treatment of uncomplicated plasmodium falciparum infections in 4 sites in India Annuppur district, Madhya Pradesh, Jhabua district, Madhya Pradesh, Bastar district, Chhattisgarh and Palamudistrict, Jharkhand
Secondary ID [1] 284779 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 292155 0
Condition category
Condition code
Infection 292489 292489 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Artemether-lumefantrine will be administered according to body weight, twice a day over 3 days, as per WHO recommended dose (WHO guidelines). Tablets containing 20mg base of artemether and 120 mg base of lumefantrine will be administered orally. The number of tablets administered is based on the weight of the patient, twice a day, over three days – 1 tablet for patients of 5-14kg, 2 for patients of 15-24kg, 3 for patients of 25-34kg, 4 over 34kg. All antimalarial drug(s) must be stored in a cool dry environment.

All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. 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 If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The therapeutic efficacy study will be carried out in the field clinic and 3-day treatment will be given at field clinic or their home by visiting each day for 3 days as in most malarious places public transport system is not available. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy
Intervention code [1] 289568 0
Treatment: Drugs
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292351 0
The study end-point is the classification assigned to a patient. Valid study end-points include: treatment failure, completion of the follow-up period without treatment failure (adequate clinical and parasitological response), loss to follow-up, withdrawal from study, and protocol violation. At all times, the well-being of the patient will take priority over his or her continuation in the study. Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest WHO guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response.
Timepoint [1] 292351 0
A standard physical examination will be performed at baseline (day 0 before dosing) and on days 1, 2, 3, 7, 14, 21 and 28. A complete medical history, including prior and concomitant medication, demographic information and contact details will be recorded at baseline.
Secondary outcome [1] 308751 0
Nil
Timepoint [1] 308751 0
Nil

Eligibility
Key inclusion criteria
Age between 6 months to 60 years ; Mono infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection), parasitaemia between 1000 and 100000 microliters of asexual forms; measured temperature (depending on method of measurement) or history of fever within previous 24 hours; 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 the absence of severe malnutrition.
Minimum age
6 Months
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Signs and symptoms of severe or complicated malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of severe malnutrition; febrile conditions due to diseases other than malaria or other know underlying chronic or severe diseases; regular medication which interferes with antimalarial pharmacokinetics; history of hypersensitivity reactions or contraindications to the medicine(s) being tested; positive pregnancy test or breastfeedings; unable to or unwilling to use contraception, including abstinence, for women of child-bearing age and who are sexually active.

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)
Subjects are those with malaria seeking treatment, please see inclusion criteria for further information.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no specific sequence, all subjects have same treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2014
Actual
10/06/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
352
Accrual to date
Final
Recruitment outside Australia
Country [1] 6128 0
India
State/province [1] 6128 0
Annuppur district, Madhya Pradesh
Country [2] 6129 0
India
State/province [2] 6129 0
Jhabua district, Madhya Pradesh
Country [3] 6130 0
India
State/province [3] 6130 0
Bastar district, Chhattisgarh
Country [4] 6131 0
India
State/province [4] 6131 0
Palamudistrict, Jharkhand

Funding & Sponsors
Funding source category [1] 289395 0
Charities/Societies/Foundations
Name [1] 289395 0
World Health Organization
Country [1] 289395 0
Switzerland
Primary sponsor type
Government body
Name
Indian Council of Medical Research, Ministry of Health & Family welfare
Address
Govt. of India. P.O. Box No. 4911
Ansari Nagar
New Delhi – 110029
Country
India
Secondary sponsor category [1] 288077 0
None
Name [1] 288077 0
Address [1] 288077 0
Country [1] 288077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291156 0
Ethics Review Committee, World Health Organization
Ethics committee address [1] 291156 0
Ethics committee country [1] 291156 0
Switzerland
Date submitted for ethics approval [1] 291156 0
Approval date [1] 291156 0
02/06/2014
Ethics approval number [1] 291156 0
RPC670

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

Contacts
Principal investigator
Name 45054 0
Dr Neeru Singh
Address 45054 0
Regional Medical Research Centre for Tribals
(Indian Council of Medical Research)
Nagpur Road, P.O. Garha,
Jabalpur - 482003 ( Madhya Pradesh)
Country 45054 0
India
Phone 45054 0
+91 761-2370800
Fax 45054 0
Email 45054 0
neeru.singh@gmail.com
Contact person for public queries
Name 45055 0
Neeru Singh
Address 45055 0
Regional Medical Research Centre for Tribals
(Indian Council of Medical Research)
Nagpur Road, P.O. Garha,
Jabalpur - 482003 ( Madhya Pradesh)
Country 45055 0
India
Phone 45055 0
+91 761-2370800
Fax 45055 0
Email 45055 0
neeru.singh@gmail.com
Contact person for scientific queries
Name 45056 0
Neeru Singh
Address 45056 0
Regional Medical Research Centre for Tribals
(Indian Council of Medical Research)
Nagpur Road, P.O. Garha,
Jabalpur - 482003 ( Madhya Pradesh)
Country 45056 0
India
Phone 45056 0
+91 761-2370800
Fax 45056 0
Email 45056 0
neeru.singh@gmail.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.