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Trial registered on ANZCTR


Registration number
ACTRN12617001051336
Ethics application status
Approved
Date submitted
23/06/2017
Date registered
19/07/2017
Date last updated
22/10/2021
Date data sharing statement initially provided
22/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumfantrine for the treatment of uncomplicated Plasmodium falciparum in Comores
Scientific title
Efficacy and safety of artemether-lumfantrine for the treatment of uncomplicated Plasmodium falciparum in Comores
Secondary ID [1] 292280 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 303798 0
Condition category
Condition code
Infection 303167 303167 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to assess the efficacy and safety of artemether+lumefantrine (20/120 mg in tablet) given twice daily for three days. The recommended dose by weight bands will be used as follows: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg.
All treatments will be taken orally under direct supervision by the health worker. The patient will be given artemether+lumefantrine and will be followed up for 28 days. Patients will be asked to attend the study facilities at scheduled days (days 1, 2, 3, 7, 14, 21, 28 and any other day, if required). If the patient fail to attend the scheduled days a designated member of the study team will visit the patient at home.
Intervention code [1] 298453 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302538 0
Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). This is composite primary outcome.

Enrolled patients will be assessed for parasitological and clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.
Timepoint [1] 302538 0
Days 1, 2, 3, 7, 14, 21, 28
Secondary outcome [1] 336335 0
Percent of adverse event following treatment of each drugs will be documented.
The known adverse events of:

Atemether+lumefantrine are abdominal pain, asthenia, cough, diarrhoea, dizziness, fever, headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting.

Parents or guardians of all enrolled children 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.
Timepoint [1] 336335 0
Days 1, 2, 3, 7, 14, 21, 28
Secondary outcome [2] 336336 0
Prevalence of artemisinin resistance molecular markers (K13).

Parasite DNA extracted from the dried blood spots will be analyzed by PCR and sequencing for the presence of K13 (molecular marker for artemisinin resistance).
Timepoint [2] 336336 0
Day 0 (prior to treatment)

Eligibility
Key inclusion criteria
1. age between six months and 60 years, excluding females aged 12 and above years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 500–200,000/microliter asexual forms;
4. presence of axillary temperature 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;
7. informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years.
8. informed assent from any minor participant aged from 12 to 18 years.
Minimum age
6 Months
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
2. weight under 5 kg;
3. Hemoglobin less than 8 g/dl;
4. mixed or mono-infection with another Plasmodium species detected by microscopy;
5. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference below 115 mm)
6. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
7. regular medication, which may interfere with antimalarial pharmacokinetics;
8. 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)
No concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
10/07/2017
Date of last participant enrolment
Anticipated
28/02/2018
Actual
11/12/2017
Date of last data collection
Anticipated
30/03/2018
Actual
8/01/2018
Sample size
Target
88
Accrual to date
Final
103
Recruitment outside Australia
Country [1] 9016 0
Comoros
State/province [1] 9016 0
Grande Island

Funding & Sponsors
Funding source category [1] 296822 0
Government body
Name [1] 296822 0
Ministry of Health of Comoros
Country [1] 296822 0
Comoros
Primary sponsor type
Government body
Name
Ministry of Health of Comoros
Address
BP:521, Moroni, Union des Comores
Country
Comoros
Secondary sponsor category [1] 295811 0
None
Name [1] 295811 0
Address [1] 295811 0
Country [1] 295811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298057 0
WHO ERC
Ethics committee address [1] 298057 0
20 Av. Appia,
1211 Geneva 27 Switzerland
Ethics committee country [1] 298057 0
Switzerland
Date submitted for ethics approval [1] 298057 0
14/03/2017
Approval date [1] 298057 0
16/06/2017
Ethics approval number [1] 298057 0
ERC.0002884

Summary
Brief summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Comoros

Purpose: To assess the efficacy and safety of artemether-lumefantrine for treatment of uncomplicated falciparum malaria

Objective: To assess the efficacy and safety artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections

Study Sites: Pole Sud, Pole du centre et Pole du Nord de la grande ile dans l’Union des Comores.

Study Period: The study started in July 2017 and will continue until March 2018.

Study Design: Single arm prospective study.

Patient population: Febrile patients aged between 6 months and 60 years, inclusive, with confirmed uncomplicated P. falciparum infection. Female 12 years will be excluded as subjecting them to pregnancy testing is unacceptable according to the local customs and cultures.

Sample Size: 88 patients will be enrolled.

Treatments and follow-up: artemether-lumefantrine (twice daily dose for 3 days) will be given. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy and safety.

Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Day 3 malaria positivity rate will determined.
Secondary endpoints: The frequency of adverse events and frequency of molecular markers for artemisinin resistance (K13)
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75846 0
Dr Rahamatou SILAI
Address 75846 0
Moroni Coulee, BP 2108, Moroni, Grande Comore
Country 75846 0
Comoros
Phone 75846 0
+269752110
Fax 75846 0
Email 75846 0
[email protected]
Contact person for public queries
Name 75847 0
Rahamatou SILAI
Address 75847 0
Moroni Coulee, BP 2108, Moroni, Grande Comore
Country 75847 0
Comoros
Phone 75847 0
+269752110
Fax 75847 0
Email 75847 0
[email protected]
Contact person for scientific queries
Name 75848 0
Rahamatou SILAI
Address 75848 0
Moroni Coulee, BP 2108, Moroni, Grande Comore
Country 75848 0
Comoros
Phone 75848 0
+269752110
Fax 75848 0
Email 75848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13727Study protocol  [email protected]
13728Informed consent form  [email protected]
13729Ethical approval  [email protected]



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.