Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12616001451493
Ethics application status
Approved
Date submitted
5/10/2016
Date registered
17/10/2016
Date last updated
5/03/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated falciparum malaria in Bangui and Boali in Central African Republic
Query!
Scientific title
Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated falciparum malaria in children in Bangui and Boali in Central African Republic
Query!
Secondary ID [1]
290276
0
Nil
Query!
Universal Trial Number (UTN)
Nil
Query!
Trial acronym
Nil
Query!
Linked study record
Nil
Query!
Health condition
Health condition(s) or problem(s) studied:
Malaria
300509
0
Query!
Condition category
Condition code
Infection
300366
300366
0
0
Query!
Studies of infection and infectious agents
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
To assess the efficacy and safety of artemether+lumefantrine (20 mg artemether and 120 mg lumefantrine in a tablet) for the treatment of uncomplicated P. falciparum infection. The doses of artemether+lumefantrine are based on weight bands: one tablet to those weighing 5 to14kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for greater than or equal to 35 kg. The treatment will be taken orally under direct supervision by the health worker. Eligible subjects will be treated twice daily for three days and followed up for 28 days.
Query!
Intervention code [1]
296072
0
Treatment: Drugs
Query!
Comparator / control treatment
No control group.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
299823
0
Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). This is a composite primary outcome.
Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.
Query!
Assessment method [1]
299823
0
Query!
Timepoint [1]
299823
0
Days 1, 2, 3, 7, 14, 21 and 28 following initiation of artemether+lumefantrine treatment
Query!
Secondary outcome [1]
328201
0
Percent of adverse event will be documented.
The known adverse events of artemether+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 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.
Query!
Assessment method [1]
328201
0
Query!
Timepoint [1]
328201
0
Days 1, 2, 3, 7, 14, 21 and 28 following initiation of artemether+lumefantrine treatment
Query!
Secondary outcome [2]
328202
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).
Query!
Assessment method [2]
328202
0
Query!
Timepoint [2]
328202
0
Day 0 (before treatment)
Query!
Eligibility
Key inclusion criteria
1. age between 6 month and 12 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000 - 200000/mocroliter asexual forms;
4. presence of axillary temperature greater than or equal 37.5 degrees cntigrade 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 parent or guardian;
Query!
Minimum age
6
Months
Query!
Query!
Maximum age
12
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
2. weight under 5 kg;
3. haemoglobin less than 8g/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 who has a mid-upper arm circumference < 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);
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
The treatment failure rate to artemether+lumefantrine in the study areas is estimated to 5%. At a confidence level of 95% and a precision around the estimate of 5%, a minimum of 73 patients will be included. With a 20% increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 88 patients per site will be included in the study. A total of 352 patients will be enrolled.
The WHO excel software programs will be used for data management and analysis. Data will be analysed by two methods: the Kaplan-Meier method and per-protocol analysis. In addition to the reasons for withdrawal, patients will be considered withdrawn from the analysis if the PCR results are unclassifiable or if the results of PCR indicate that the failure is due to reinfection with P. falciparum or P. vivax.
The final analysis will include:
1. a description of all patients screened and the distribution of reasons for non-inclusion in the study;
2. a description of all the patients included in the study;
3. the proportion of adverse events and serious adverse events in all the patients included in the study;
4. the proportion of patients lost to follow-up or withdrawn, with 95% confidence intervals and a list of reasons for withdrawal;
5. the cumulative incidence of success and failure rates at day 28, PCR-uncorrected and PCR-corrected; and
6. the proportion of early treatment failure, late clinical failure, late parasitological failure and adequate clinical and parasitological response at day 28, with 95% confidence intervals, PCR-uncorrected and PCR-corrected.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
30/11/2016
Query!
Actual
26/01/2017
Query!
Date of last participant enrolment
Anticipated
30/11/2017
Query!
Actual
11/03/2017
Query!
Date of last data collection
Anticipated
28/12/2017
Query!
Actual
11/04/2017
Query!
Sample size
Target
176
Query!
Accrual to date
Query!
Final
125
Query!
Recruitment outside Australia
Country [1]
8295
0
Central African Republic
Query!
State/province [1]
8295
0
Bangui in Ombella-M'Poko and Boali
Query!
Funding & Sponsors
Funding source category [1]
294645
0
Government body
Query!
Name [1]
294645
0
Ministry of Health
Query!
Address [1]
294645
0
Avenue Gamal Abdel Nasser
BP: 883, Bangui
Query!
Country [1]
294645
0
Central African Republic
Query!
Primary sponsor type
Government body
Query!
Name
Ministry of Health
Query!
Address
Avenue Gamal Abdel Nasser
BP: 883, Bangui
Query!
Country
Central African Republic
Query!
Secondary sponsor category [1]
293509
0
None
Query!
Name [1]
293509
0
None
Query!
Address [1]
293509
0
None
Query!
Country [1]
293509
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
296083
0
WHO Ethics Review Committee
Query!
Ethics committee address [1]
296083
0
20, AVENUE APPIA – CH-1211 GENEVA 27 – SWITZERLAND
Query!
Ethics committee country [1]
296083
0
Switzerland
Query!
Date submitted for ethics approval [1]
296083
0
14/07/2016
Query!
Approval date [1]
296083
0
30/09/2016
Query!
Ethics approval number [1]
296083
0
ERC.0002802
Query!
Summary
Brief summary
Title: Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum will be evaluated. Objective: To assess the efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated P. falciparum malaria infections in four sentinel sites. Study Sites: study will be conducted in 4 sites: in Bangui: (i) Complex Pediatric of Bangui ; (ii) Centre de sante of Lakouanga and (iii) Centre de sante of Bede Combattant; and in Boali: (iv) Centre de sante de Boali. Study Period: The study will be conducted from November 2016 to December 2017. Study Design: A one arm prospective study. Patient population: Febrile patients aged between 6 months and 12 years with confirmed uncomplicated P. falciparum infection will be enrolled. Sample Size: 88 patients per site giving a total of 352 patients. Treatments and follow-up: artemether+lumefantrine (twice daily for 3 days) will be given. Clinical and parasitological parameters will be monitored over a 28-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: 1. The frequency of adverse events. 2. Frequency of molecular markers for artemisinin resistance (K13)
Query!
Trial website
None
Query!
Trial related presentations / publications
None
Query!
Public notes
None
Query!
Contacts
Principal investigator
Name
69490
0
Dr Wilfried Sylvain NAMBEI
Query!
Address
69490
0
University of Bangui
Avenue des Martyrs, Bangui,
Query!
Country
69490
0
Central African Republic
Query!
Phone
69490
0
+23675599075
Query!
Fax
69490
0
Query!
Email
69490
0
[email protected]
Query!
Contact person for public queries
Name
69491
0
Wilfried Sylvain NAMBEI
Query!
Address
69491
0
University of Bangui
Avenue des Martyrs, Bangui,
Query!
Country
69491
0
Central African Republic
Query!
Phone
69491
0
+23675599075
Query!
Fax
69491
0
Query!
Email
69491
0
[email protected]
Query!
Contact person for scientific queries
Name
69492
0
Wilfried Sylvain NAMBEI
Query!
Address
69492
0
University of Bangui
Avenue des Martyrs, Bangui,
Query!
Country
69492
0
Central African Republic
Query!
Phone
69492
0
+23675599075
Query!
Fax
69492
0
Query!
Email
69492
0
[email protected]
Query!
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.
Download to PDF