MalariaNCT01967472
Adherence to Antimalarial Drugs in Sierra Leone
A study testing amodiaquine-artesunate (AQAS) fixed-dose and Artemether-lumefantrine combination (AL) dispersable in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in Sierra Leone.
Trial summary
The aim of this study is to address this gap in knowledge by measuring the level of patient adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key factors that influence adherence. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- amodiaquine-artesunate (AQAS) fixed-dose and Artemether-lumefantrine combination (AL) dispersable
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,145 participants
- Where
- 2 sitesSierra Leone
- Study dates
- 16 Sep 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is a child between 6 to 59 months
- Visiting health facility for treatment of fever
- Do not have signs of severe disease
- Are not being referred to another health facility
- Living within a defined distance from the health facility (<8 km/ 5 miles)
- Have not taken part in the study already or are not part of a household that has already taken part in the study
- Responsible caretakers/parents provide additional informed consent
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Sierra Leone2 sites
George Brook Health Center
Freetown
Ross Road Health Facility
Freetown
About this study
Official title: Adherence to Artemisinin-Based Combination Therapy (ACT) for the Treatment of Malaria in Sierra Leone
The aim of this study is to address this gap in knowledge by measuring the level of patient adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key factors that influence adherence. This will be addressed through a mixed methods study that will provide not only a measurement of adherence ACTs and malaria test results, but will also provide contextual information in order to better understand factors that affect adherence. Data will be collected through a series of interviews with health workers and parents/caregivers and through observations of patient-provider consultations.
The first stage of the study begins with semi-structured interviews and observations of patients/caretakers' consultations with health workers and will look at how health workers diagnose and treat malaria. This will be followed by short exit interviews at the health facility with caregivers to assess patient satisfaction with services, as well as to test the consistency between the data obtained through structured observations and the exit interviews.
Follow-up surveys at the homes of patients will be used to measure and compare the adherence of participants to two different ACTs (AQAS and AL) formulations and potential factors that affect adherence. Additionally, data will be collected using in-depth interviews to collect supplementary information in order to discover, in more detail, factors that may affect behavioral choices and/or attitudes with regard to adherence.
- Conditions
- Malaria
- Being tested
- amodiaquine-artesunate (AQAS) fixed-dose, Artemether-lumefantrine combination (AL) dispersable
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amodiaquine-artesunate (AQAS) fixed-doseDrug
Also called coarsucam, winthrop, co-formulated
Artemether-lumefantrine combination (AL) dispersableDrug
Also called coartem, AL, locally all Artemether-lumefantrine called 'lokmal'
| Study group | Role | What they receive |
|---|---|---|
| co-formulated Amodiaquine-Artesunate | Active comparator | Sanofi Coarsucam Infant dose (2-12 months/4.5-8kg), amodiaquine:67.5mg/artesunate 25mg; 1 tablet once a day for 3 days.
Sanofi Coarsucam Young Child (13-59 months/9-17kg), amodiaquine: 136mg/artesunate 50mg; 1 tablet once a day for 3 days. Receives: Drug: amodiaquine-artesunate (AQAS) fixed-dose |
| artemether-lumefantrine | Active comparator | Novartis coartem infant dose (2-11 months/5-14kg), artemether 20mg/lumefantrine 120mg; 1 tablet twice a day for 3 days.
Novartis coartem child dose (12-59 months/15-24kg), artemether 20mg/lumefantrine 120mg; 2 tablets twice a day for 3 days Receives: Drug: Artemether-lumefantrine combination (AL) dispersable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Adherence is measured on the day following the last day of treatment. Adherence is defined as taking all of the prescribed dose at the correct time.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study start16 Sep 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Malaria Control Program, Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
- Responsible party
- Sponsor
- Investigators
- Kristin Banek, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967472
- Sponsor's protocol ID
- SL-ACT-01
- Status last verified
- Jan 2018
- First submitted
- 18 Oct 2013
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Banek K, Webb EL, Smith SJ, Chandramohan D, Staedke SG. Adherence to treatment with artemether-lumefantrine or amodiaquine-artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial. Malar J. 2018 Jun 4;17(1):222. doi: 10.1186/s12936-018-2370-x.
PubMed 29866192
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Artemisinin-Based Combination Therapy (ACT) for the Treatment of Malaria in Sierra Leone
- ClinicalTrials.gov ID
- NCT01967472
- Acronym / sponsor ID
- SL-ACT-01
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,145 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- National Malaria Control Program, Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
- Study start
- 16 Sep 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to address this gap in knowledge by measuring the level of patient adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key factors that influence adherence. This will be addressed through a mixed methods study that will provide not only a measurement of adherence ACTs and malaria test results, but will also provide contextual information in order to better understand factors that affect adherence. Data will be collected through a series of interviews with health workers and parents/caregivers and through observations of patient-provider consultations.
The first stage of the study begins with semi-structured interviews and observations of patients/caretakers' consultations with health workers and will look at how health workers diagnose and treat malaria. This will be followed by short exit interviews at the health facility with caregivers to assess patient satisfaction with services, as well as to test the consistency between the data obtained through structured observations and the exit interviews.
Follow-up surveys at the homes of patients will be used to measure and compare the adherence of participants to two different ACTs (AQAS and AL) formulations and potential factors that affect adherence. Additionally, data will be collected using in-depth interviews to collect supplementary information in order to discover, in more detail, factors that may affect behavioral choices and/or attitudes with regard to adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| co-formulated Amodiaquine-Artesunate | Active comparator | Drug: amodiaquine-artesunate (AQAS) fixed-doseSanofi Coarsucam Infant dose (2-12 months/4.5-8kg), amodiaquine:67.5mg/artesunate 25mg; 1 tablet once a day for 3 days. Sanofi Coarsucam Young Child (13-59 months/9-17kg), amodiaquine: 136mg/artesunate 50mg; 1 tablet once a day for 3 days. |
| artemether-lumefantrine | Active comparator | Drug: Artemether-lumefantrine combination (AL) dispersableNovartis coartem infant dose (2-11 months/5-14kg), artemether 20mg/lumefantrine 120mg; 1 tablet twice a day for 3 days. Novartis coartem child dose (12-59 months/15-24kg), artemether 20mg/lumefantrine 120mg; 2 tablets twice a day for 3 days |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patient is a child between 6 to 59 months
- Visiting health facility for treatment of fever
- Do not have signs of severe disease
- Are not being referred to another health facility
- Living within a defined distance from the health facility (<8 km/ 5 miles)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amodiaquine-artesunate (AQAS) fixed-doseAlso: coarsucam, winthrop, co-formulated | Drug | co-formulated Amodiaquine-Artesunate |
| Artemether-lumefantrine combination (AL) dispersableAlso: coartem, AL, locally all Artemether-lumefantrine called 'lokmal' | Drug | artemether-lumefantrine |
Primary outcome
Adherence
Time frame: Day 4
Adherence is measured on the day following the last day of treatment. Adherence is defined as taking all of the prescribed dose at the correct time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Derived from this study: PubMed 29866192Banek K, Webb EL, Smith SJ, Chandramohan D, Staedke SG. Adherence to treatment with artemether-lumefantrine or amodiaquine-artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial. Malar J. 2018 Jun 4;17(1):222. doi: 10.1186/s12936-018-2370-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Banek principal investigator
London School of Hygiene and Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amodiaquine-artesunate (AQAS) fixed-dose and Artemether-lumefantrine combination (AL) dispersable in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01967472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.