MalariaPhase 4NCT04897919
Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for Treating Malaria
A Phase 4 study testing Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet and Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet in people with Malaria and Effectiveness, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (> 6 months) suffering from uncomplicated P. falciparum malaria. Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria, Effectiveness
- What is being tested?
- Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet and Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 1 Aug 2015to 1 Dec 2018
- Phase
- Phase 4
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mono-infection with P. falciparum detected by microscopy.
- Parasitemia of 1.000-200.000/µl asexual forms.
- Axillary temperature ≥37.5 ˚C or a history of fever within 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.
- Informed consent
Who cannot join
- Signs or symptoms of severe malaria
- Presence of general danger signs in children under 5
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to AL, DP or quinine.
- Domicile outside the study area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau
Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (> 6 months) suffering from uncomplicated P. falciparum malaria.
Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed.
Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.
Read the detailed description
To objective of the study:
- To measure the efficacy and safety of AL and DP in children for treating uncomplicated P. falciparum malaria.
- To determine the capacity of each drug combination to protect against re-infection.
- To differentiate recrudescence from re-infections using PCR based methods
- To determine haemoglobin values on days 0 and 42
- To determine genetic polymorphisms in P. falciparum causing reparasitaemia. Study design This will be an open label, randomized, non inferiority trial conducted at the Bandim Health Centre, Guinea-Bissau. Patients with uncomplicated malaria who meet study inclusion criteria will be enrolled, randomised to treatment with either AL or DP. Medication will be provided and first dose given at the health centre.
Efficacy and safety evaluation Treatment outcomes will be early treatment failure, late clinical failure, late parasitological failure or adequate clinical and parasitological response as defined by the WHO. All 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 in the case record forms.
100µL of blood will be collected on Whatman 3MM filter-paper using a capillary tube on day 0, 7, 14, 28,and 42 and whenever re-parasitaemia is detected. Filter-papers will be dried and then placed inside separate sealed plastic bags.
In order to differentiate recrudescence from a re-infection genotyping using sequential analysis of pf-glurp, pfmsp1 and pfmsp2 will be done. Drug concentrations will be assessed on the week prior to re-parasitaemia. Haemoglobin concentration will be determined on day 0, 3 and 42 using a haemocueTM.
- Conditions
- Malaria, Effectiveness
- Being tested
- Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet, Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquine 160 mg/20 mg Oral TabletDrug
Also called Eurartesim
Dihydroartemisinin-piperaquine is given as recommended by manufacturer and compared to the Artemether-lumefantrine group.
Artemether-Lumefantrine 20 Mg-120 Mg Oral TabletDrug
Also called Coartem
Artemether-Lumefantrine is given as recommended by manufacturer
| Study group | Role | What they receive |
|---|---|---|
| dihydroartemisinin-piperaquine | Experimental | First dose will be given supervised. The rest will be provided and the parents should take it at home.
Dihydroartemisinin-piperaquine dosing as recommended by manufacturer Receives: Drug: Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet |
| artemether-lumefantrine | Active comparator | First dose will be given supervised. The rest will be provided and the patients should take it at home.
Artemether-lumefantrine dosing as recommended by manufacturer Receives: Drug: Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate clinical and parasitological response rate at day 42
Cumulative percentages of children having successful treatment on day 42.
Measured: Day 42
Secondary outcomes (2)
re-infection vs recrudescence
Cumulative re-infection and recrudescence rates
Measured: Day 42
Haemoglobin level
Haemoglobin measured on day 42
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Aug 2015
- Primary completion1 Oct 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897919
- Sponsor's protocol ID
- Eurartesim2015
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2015
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau
- ClinicalTrials.gov ID
- NCT04897919
- Acronym / sponsor ID
- Eurartesim2015
- Conditions
- Malaria, Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 24 May 2021 (actual)
- 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.
Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (> 6 months) suffering from uncomplicated P. falciparum malaria.
Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed.
Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.
Detailed description
To objective of the study:
- To measure the efficacy and safety of AL and DP in children for treating uncomplicated P. falciparum malaria.
- To determine the capacity of each drug combination to protect against re-infection.
- To differentiate recrudescence from re-infections using PCR based methods
- To determine haemoglobin values on days 0 and 42
- To determine genetic polymorphisms in P. falciparum causing reparasitaemia. Study design This will be an open label, randomized, non inferiority trial conducted at the Bandim Health Centre, Guinea-Bissau. Patients with uncomplicated malaria who meet study inclusion criteria will be enrolled, randomised to treatment with either AL or DP. Medication will be provided and first dose given at the health centre.
Efficacy and safety evaluation Treatment outcomes will be early treatment failure, late clinical failure, late parasitological failure or adequate clinical and parasitological response as defined by the WHO. All 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 in the case record forms.
100µL of blood will be collected on Whatman 3MM filter-paper using a capillary tube on day 0, 7, 14, 28,and 42 and whenever re-parasitaemia is detected. Filter-papers will be dried and then placed inside separate sealed plastic bags.
In order to differentiate recrudescence from a re-infection genotyping using sequential analysis of pf-glurp, pfmsp1 and pfmsp2 will be done. Drug concentrations will be assessed on the week prior to re-parasitaemia. Haemoglobin concentration will be determined on day 0, 3 and 42 using a haemocueTM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dihydroartemisinin-piperaquine | Experimental | Drug: Dihydroartemisinin-piperaquine 160 mg/20 mg Oral TabletFirst dose will be given supervised. The rest will be provided and the parents should take it at home. Dihydroartemisinin-piperaquine dosing as recommended by manufacturer |
| artemether-lumefantrine | Active comparator | Drug: Artemether-Lumefantrine 20 Mg-120 Mg Oral TabletFirst dose will be given supervised. The rest will be provided and the patients should take it at home. Artemether-lumefantrine dosing as recommended by manufacturer |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Mono-infection with P. falciparum detected by microscopy.
- Parasitemia of 1.000-200.000/µl asexual forms.
- Axillary temperature ≥37.5 ˚C or a history of fever within 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.
Key exclusion criteria (7 listed)
- Signs or symptoms of severe malaria
- Presence of general danger signs in children under 5
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
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 |
|---|---|---|
| Dihydroartemisinin-piperaquine 160 mg/20 mg Oral TabletAlso: EurartesimDihydroartemisinin-piperaquine is given as recommended by manufacturer and compared to the Artemether-lumefantrine group. | Drug | dihydroartemisinin-piperaquine |
| Artemether-Lumefantrine 20 Mg-120 Mg Oral TabletAlso: CoartemArtemether-Lumefantrine is given as recommended by manufacturer | Drug | artemether-lumefantrine |
Primary outcome
Adequate clinical and parasitological response rate at day 42
Time frame: Day 42
Cumulative percentages of children having successful treatment on day 42.
2 secondary outcomes
re-infection vs recrudescence
Time frame: Day 42
Haemoglobin level
Time frame: Day 42
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 12 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet and Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet in people with Malaria and Effectiveness, run by Bandim Health Project at 1 site in Guinea-Bissau.
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 6 inclusion and 7 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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adequate clinical and parasitological response rate at day 42 (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022.