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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
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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
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Secondary ID [1]
284779
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malaria
292155
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Condition category
Condition code
Infection
292489
292489
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
289568
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Treatment: Drugs
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Comparator / control treatment
No control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
292351
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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.
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Secondary outcome [1]
308751
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Nil
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Assessment method [1]
308751
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Timepoint [1]
308751
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Nil
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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.
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Minimum age
6
Months
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no specific sequence, all subjects have same treatment.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
10/06/2014
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Actual
10/06/2014
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Date of last participant enrolment
Anticipated
31/03/2015
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
352
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
6128
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India
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State/province [1]
6128
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Annuppur district, Madhya Pradesh
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Country [2]
6129
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India
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State/province [2]
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Jhabua district, Madhya Pradesh
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Country [3]
6130
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India
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State/province [3]
6130
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Bastar district, Chhattisgarh
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Country [4]
6131
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India
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State/province [4]
6131
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Palamudistrict, Jharkhand
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Funding & Sponsors
Funding source category [1]
289395
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Charities/Societies/Foundations
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Name [1]
289395
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World Health Organization
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Address [1]
289395
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Avenue Appia 20
CH 1211 Geneva 20
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Country [1]
289395
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Switzerland
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Primary sponsor type
Government body
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Name
Indian Council of Medical Research, Ministry of Health & Family welfare
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Address
Govt. of India. P.O. Box No. 4911
Ansari Nagar
New Delhi – 110029
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Country
India
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Secondary sponsor category [1]
288077
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None
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Name [1]
288077
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Address [1]
288077
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Country [1]
288077
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291156
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Ethics Review Committee, World Health Organization
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Ethics committee address [1]
291156
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Avenue Appia 20
CH 1211 Geneva 20
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Ethics committee country [1]
291156
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Switzerland
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Date submitted for ethics approval [1]
291156
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Approval date [1]
291156
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02/06/2014
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Ethics approval number [1]
291156
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RPC670
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Summary
Brief summary
To study the efficacy of antimalarial drugs in India
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Neeru Singh
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Address
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Regional Medical Research Centre for Tribals
(Indian Council of Medical Research)
Nagpur Road, P.O. Garha,
Jabalpur - 482003 ( Madhya Pradesh)
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Country
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India
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Phone
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+91 761-2370800
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Neeru Singh
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Address
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Regional Medical Research Centre for Tribals
(Indian Council of Medical Research)
Nagpur Road, P.O. Garha,
Jabalpur - 482003 ( Madhya Pradesh)
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Country
45055
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India
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Phone
45055
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+91 761-2370800
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Fax
45055
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Email
45055
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[email protected]
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Contact person for scientific queries
Name
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Dr Neeru Singh
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Address
45056
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Regional Medical Research Centre for Tribals
(Indian Council of Medical Research)
Nagpur Road, P.O. Garha,
Jabalpur - 482003 ( Madhya Pradesh)
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Country
45056
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India
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Phone
45056
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+91 761-2370800
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Fax
45056
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Email
45056
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[email protected]
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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.
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