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Trial registered on ANZCTR


Registration number
ACTRN12610000895088
Ethics application status
Approved
Date submitted
19/10/2010
Date registered
21/10/2010
Date last updated
4/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in sentinel sites of Comores
Scientific title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in sentinel sites of Comores
Secondary ID [1] 252908 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 258444 0
Condition category
Condition code
Infection 258608 258608 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One arm propective evaluation with artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria.

Dose regimen:
Atemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrince twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg bw: 3 tablets and greater than or equal to 35 kg body weight (bw): 4 tablets. All treatment will be orally taken tablets.
Intervention code [1] 257439 0
Treatment: Drugs
Comparator / control treatment
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] 259457 0
% of artemether-lumefantrine treatment failures (early treatment failure+late clinical failure+late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).
Timepoint [1] 259457 0
At 28 day following treatment
Primary outcome [2] 259458 0
% of adverse events in the artemether-lumefantrine treated groups. 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 [2] 259458 0
At 28 day following treatment
Secondary outcome [1] 266014 0
Nil
Timepoint [1] 266014 0
Nil

Eligibility
Key inclusion criteria
*age between 6 and 59 months inclusive in Ngazidja and Ndzouani sites and between 6 months and 12 years inclusive in Mwali site;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 2000-200,000/microliterl asexual forms) except at Mwali site 1000-200000/microliter;
*presence of axillary equal to or more than 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
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*presence 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 below 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);

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 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)
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
Not Applicable
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] 2981 0
Comoros
State/province [1] 2981 0

Funding & Sponsors
Funding source category [1] 257879 0
Government body
Name [1] 257879 0
Ministry of Health, Solidatrity and promotion of Gendre
Address [1] 257879 0
P.O. Box 446, Moroni
Country [1] 257879 0
Comoros
Primary sponsor type
Government body
Name
Ministry of Health, Solidarity and Propotion of gender
Address
P.O. Box 446, Moroni
Country
Comoros
Secondary sponsor category [1] 257090 0
None
Name [1] 257090 0
Address [1] 257090 0
Country [1] 257090 0
Other collaborator category [1] 251608 0
Other Collaborative groups
Name [1] 251608 0
Institut Pasteur de Madagascar(IPM)
Address [1] 251608 0
IPM - Institut Pasteur de Madagascar
B.P. 1274
Ambatofotsikely
101 Antananarivo
Country [1] 251608 0
Madagascar

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259905 0
Ethical Review Committee , World Health Organization (ERC, WHO)
Ethics committee address [1] 259905 0
20 Avenue Appia, CH-1211 Geneva 27
Ethics committee country [1] 259905 0
Switzerland
Date submitted for ethics approval [1] 259905 0
06/09/2010
Approval date [1] 259905 0
06/09/2010
Ethics approval number [1] 259905 0
RPC418
Ethics committee name [2] 260117 0
Ministry of Health, Solidarity and Promotion of Gender
Ethics committee address [2] 260117 0
P.O. Box 446 Moroni
Ethics committee country [2] 260117 0
Comoros
Date submitted for ethics approval [2] 260117 0
Approval date [2] 260117 0
09/08/2010
Ethics approval number [2] 260117 0
Ref. No 10/66/MSSPG/DNS

Summary
Brief summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria, in sentinel sites of of the three islands (Ngazidja), Mwali et Ndzouani) of Comoros. Background: Therapeutic efficacy studies will be done in Comoros to assess the efficacy and safety of artemether-lumefantrinefor the treatment of uncomplicated falciparum malaria. The study will be conducted in Ngazidja (Moroni et Foumbouni), Mwali (Wanani et Nioumachoua) et Ndzouani (Pomoni et Domoni) islands. The participants will be febrile people between 6 and 59 months, inclusive, except in Mwali between 6 months and 12 years, inclusive. Patients will be treated with artemether-lumefantrine twice a day over 3 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 Comoros in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Trial website
Trial related presentations / publications
Trial related presentations/publications are not available
Public notes

Contacts
Principal investigator
Name 31803 0
Dr Rahamatou SILAI
Address 31803 0
Ministry of health, Solidarity and Propotion of Gender P.O. Box 446 Moroni
Country 31803 0
Comoros
Phone 31803 0
+2693330375
Fax 31803 0
Email 31803 0
rsilai.pnlp@laposte.net
Contact person for public queries
Name 15050 0
Dr Rahamatou SILAI
Address 15050 0
Ministry of health, Solidarity and Propotion of Gender
P.O. Box 446
Moroni
Country 15050 0
Comoros
Phone 15050 0
+2693330375
Fax 15050 0
+269763 2080
Email 15050 0
rsilai.pnlp@laposte.net
Contact person for scientific queries
Name 5978 0
Dr Rahamatou SILAI
Address 5978 0
Ministry of health, Solidarity and Propotion of Gendre
P.O. Box 446
Moroni
Country 5978 0
Comoros
Phone 5978 0
+2693330375
Fax 5978 0
+269763 2080
Email 5978 0
rsilai.pnlp@laposte.net

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