MALARIAPhase 4NCT05070520
Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites
A Phase 4 study testing Artemether-lumefantrine in people with MALARIA, run by Programme National de Lutte contre le Paludisme, Niger at 1 site in Niger.
Trial summary
In Niger, malaria is a major public health problem. It is the main cause of morbidity and mortality among children. The management of malaria cases is based on the principle of early diagnosis and rapid treatment with effective drugs. Read more about this study
- Who is it for?
- Ages 3 months to 15 years
- Conditions the study is for
- MALARIA
- What is being tested?
- Artemether-lumefantrine
- How many people
- 259 participants
- Where
- 1 siteNiger
- Study dates
- 1 Sep 2020to 28 Oct 2020
- 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 3 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Brachial circumference (BC) > 125 mm and P/T z-score > -2 Standard Deviation (SD)
- Age between three months and fifteen years,
- Monospecific Plasmodium falciparum infestation detected by microscopy;
- Parasitemia between 1000 and 200000 asexual parasitic forms/µl ;
- Axillary temperature ≥37.5° or history of fever in the past 24 hours ;
- Ability to take oral medications;
- Ability and willingness to adhere to the protocol for the duration of the study and to adhere to the visit schedule ;
- Informed consent of the accompanying person (guardian or parent).
Who cannot join
- Inability to take oral medications
- History of antimalarial treatment in the past two weeks, including sulfadoxine-pyrimethamine (SPAQ) for seasonal malaria chemoprevention (SMC)
- Lack of consent for pregnancy testing
- Presence of general danger signs in children under five years of age or signs of severe P. falciparum malaria as defined by World Health Organization (WHO);
- Mixed infestation or monospecific infestation with another Plasmodium species, detected by microscopic examination;
- Severe malnutrition defined by a BC <125 mm AND P/T z-score < -3 Standard Deviation (SD)
Show all 11Show fewer
- Moderate malnutrition defined by a BC <125 mm AND a -3 ≤P/T z-score < -2 SD
- Febrile condition due to illnesses other than malaria (e.g., measles, acute lower respiratory tract infection, severe diarrheal illness with dehydration) or other known chronic or severe underlying illnesses (e.g., cardiac, renal, or liver disease, HIV/AIDS) ;
- Regular use of medications that may interfere with antimalarial pharmacokinetics;
- History of hypersensitivity or contraindication to any of the drugs tested or used as replacement therapy;
- Lack of informed consent from the patient or accompanying person
Trial locations and contacts
1 site in 1 country.
About this study
In Niger, malaria is a major public health problem. It is the main cause of morbidity and mortality among children. The management of malaria cases is based on the principle of early diagnosis and rapid treatment with effective drugs. It is confronted with the appearance of strains resistant to antimalarial drugs, hence the need to monitor antimalarial drug sensitivity.
The study was conducted in three regions representing epidemiological strata of the country: Agadez (Centre de santé Intégré of Dagamanet in the Health district of Agadez), Maradi (Centre de santé intégré of Guindaoua in Tessaoua) and Dosso (Centre de santé Intégré centre in Gaya). The protocol used is the WHO standardized protocol of 2009. Artemether/Lumefantrine (AL) was administered with a 28-day follow-up in children aged 3 months to 15 years. A Polymerase Chain Reaction (PCR) correction is planned to differentiate between treatment failure and re-infestation as well as a study of genes responsible for resistance on the main drugs used.
Read the detailed description
The study took place from September 1 to October 31, 2020 at the time of peak malaria transmission. It took place at three sentinel sites of the National Malaria Control Program (NMCP). These were in the regions of i) Agadez at the Centre de Santé Intégré (CSI) of Dagamanet in the Agadez district, ii) Dosso at the CSI centre in the health district (HD) of Gaya iii) Maradi at the CSI Guindaoua in the HD of Tessaoua. These sites were identified by the NMCP because of their high attendance rate and belong to 3 different malaria epidemiological strata.
As the treatment failure rate of artemether lumefantrine (AL) in the regions is unknown, 5% was chosen. With a confidence level of 95% and a precision around the estimate of 5%, a minimum of 73 patients were included. The number of patients was increased by 20% to account for possible dropouts and withdrawals during the 28/42 day follow-up period, 88 patients were included in the study per site.
The study drug is oral AL. It is one of the four antimalarial drugs selected by the Niger's NMCP for the management of malaria. The product consists of blister packs of 6 tablets, box of 30 of lot number K U142 with an expiration date of January 2022 and blister packs of 12 tablets, box of 30 of lot number K U456 with an expiration date of January 2022.
The AL combination was administered at a dose of 4 mg artemether and 24 mg lumefantrine per kg for three days. The AL was provided by the NMCP.
The different prescriptions were as follows:
- 5 to 15 Kg: 1 tablet, twice a day for three days.
- 15 to 25 Kg: 2 tablets, twice a day for three days.
- 25 to 35 kg: 3 tablets, twice a day for three days.
- Over 35 kg: 4 tablets, twice a day for three days.
The first day's intake was done under direct observation and possible side effects were noted. Any patient who persistently vomited after taking the medication was excluded from the study and treated with artesunate. Patients were followed up regularly until Day 28 and received a clinical examination with thick drop control and axillary temperature taking at Day 0, Day 1, Day 2, Day 3, Day 7, Day 14, Day 21, and Day 28. Capillary blood on filtered paper (Wattman) was routinely collected from all patients on the day of inclusion ( Day 0) and during follow-up for molecular analysis. For follow-up, the density of asexual parasite forms was assessed on the basis of 8 000 leukocytes per microliter of blood. All slides were read by two microscopists to ensure control. At the end of the follow-up, the response to treatment was classified according to clinical and parasitological criteria
- Conditions
- MALARIA
- Being tested
- Artemether-lumefantrine
- Keywords
- Malaria, Efficacy, Arthemeter, Lumefantrine, Niger
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
Efficacy of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sentinel sites in Niger (Agadez, Gaya and Tessaoua) in 2020
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with asexual falciparum parasitaemia on Day 0.
Parasitaemia always refers to falciparum species. Mixed infections detected by light microscopy was excluded.
Measured: 4 weeks
Number of patiants with presence of gametocytes on Day 0
Measured: 4 weeks
Percentage of patients with danger signs of malaria on Day 1
Depending on the classification, a patient will be considered as having experienced treatment failure if the danger signs are associated with the presence of parasites.
Measured: 4 weeks
Proportion of patients with 'adequate clinical and parasitological response' (ACPR) before PCR-corrected
absence of parasitaemia on day 28 (day 42), irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure
Measured: 8 weeks
Proportion of patients with 'adequate clinical and parasitological response' (ACPR) after PCR-corrected
PCR analysis
Measured: 24 weeks
Proportion of patients with 'early treatment failure' (ETF) before PCR-corrected
- Danger signs or severe malaria on day 1, 2 or 3, in the presence of parasitaemia;
- Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature;
- Parasitaemia on day 3 with axillary temperature ≥ 37.5 °C; and
- Parasitaemia on day 3 ≥ 25% of count on day 0
Measured: 8 weeks
Proportion of patients with 'early treatment failure' (ETF) after PCR-corrected
-PCR analysis
Measured: 24 weeks
Proportion of patients with 'late clinical failure' (LCF) before PCR-corrected
- danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 (day 42) in patients who did not previously meet any of the criteria of early treatment failure; and
- presence of parasitaemia on any day between day 4 and day 28 (day 42) with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure
Measured: 8 weeks
Proportion of patients with 'late clinical failure' (LCF) after PCR-corrected
PCR analysis
Measured: 24 weeks
Proportion of patients with 'late parasitological failure' (LPF) before PCR-corrected
presence of parasitaemia on any day between day 7 and day 28 (day 42) with axillary temperature < 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.
Measured: 8 weeks
Proportion of patients with 'late parasitological failure' (LPF) after PCR-corrected
PCR analysis
Measured: 24 weeks
Percentage of the known mutations associated with artemisinin resistance observed.
PCR analysis
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Sep 2020
- Primary completion30 Sep 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This surveillance study is a prospective one-arm evaluation of clinical and parasitological responses to treatment of uncomplicated malaria with direct observation of treatment. Individuals with uncomplicated malaria, who meet the study inclusion criteria, will be recruited and treated at the sites by AL. They will be monitored for 28 days. Follow-up will consist of a series of fixed-date monitoring visits and corresponding clinical examinations and laboratory tests. Based on the results of these assessments, patients will be classified as having treatment failure (early or late) or adequate response. The proportion of patients with treatment failure during follow-up will be used to assess the efficacy of the study drugs. PCR analysis will be used to distinguish between true recrudescence due to treatment failure and episodes of re-infestation. A proportion of 10% of the slides read in the field will be submitted for quality control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Programme National de Lutte contre le Paludisme, Niger
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hadiza JACKOU, Dr, Principal investigator, PROGRAMME NATIONAL DE LUTTE CONTRE LE PALUDISME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070520
- Sponsor's protocol ID
- 033/2020/CNERS
- Status last verified
- Oct 2021
- First submitted
- 24 Sep 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data could be used for thesis
Publications
Severe falciparum malaria. World Health Organization, Communicable Diseases Cluster. Trans R Soc Trop Med Hyg. 2000 Apr;94 Suppl 1:S1-90. No abstract available.
PubMed 11103309Laminou IM, Issa I, Adehossi E, Maman K, Jackou H, Coulibaly E, Tohon ZB, Ahmed J, Sanoussi E, Koko D. Therapeutic efficacy and tolerability of artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria in Niger, 2020. Malar J. 2024 May 13;23(1):144. doi: 10.1186/s12936-024-04945-8.
PubMed 38741101
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antimalarial Drugs Used for the Treatment of Uncomplicated Malaria, Plasmodium Falciparum, at the Agadez, Gaya and Tessaoua Sentinel Sites
- ClinicalTrials.gov ID
- NCT05070520
- Acronym / sponsor ID
- 033/2020/CNERS
- Conditions
- MALARIA
- Keywords
- Malaria, Efficacy, Arthemeter, Lumefantrine, Niger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Programme National de Lutte contre le Paludisme, NigerOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 7 Oct 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.
In Niger, malaria is a major public health problem. It is the main cause of morbidity and mortality among children. The management of malaria cases is based on the principle of early diagnosis and rapid treatment with effective drugs. It is confronted with the appearance of strains resistant to antimalarial drugs, hence the need to monitor antimalarial drug sensitivity.
The study was conducted in three regions representing epidemiological strata of the country: Agadez (Centre de santé Intégré of Dagamanet in the Health district of Agadez), Maradi (Centre de santé intégré of Guindaoua in Tessaoua) and Dosso (Centre de santé Intégré centre in Gaya). The protocol used is the WHO standardized protocol of 2009. Artemether/Lumefantrine (AL) was administered with a 28-day follow-up in children aged 3 months to 15 years. A Polymerase Chain Reaction (PCR) correction is planned to differentiate between treatment failure and re-infestation as well as a study of genes responsible for resistance on the main drugs used.
Detailed description
The study took place from September 1 to October 31, 2020 at the time of peak malaria transmission. It took place at three sentinel sites of the National Malaria Control Program (NMCP). These were in the regions of i) Agadez at the Centre de Santé Intégré (CSI) of Dagamanet in the Agadez district, ii) Dosso at the CSI centre in the health district (HD) of Gaya iii) Maradi at the CSI Guindaoua in the HD of Tessaoua. These sites were identified by the NMCP because of their high attendance rate and belong to 3 different malaria epidemiological strata.
As the treatment failure rate of artemether lumefantrine (AL) in the regions is unknown, 5% was chosen. With a confidence level of 95% and a precision around the estimate of 5%, a minimum of 73 patients were included. The number of patients was increased by 20% to account for possible dropouts and withdrawals during the 28/42 day follow-up period, 88 patients were included in the study per site.
The study drug is oral AL. It is one of the four antimalarial drugs selected by the Niger's NMCP for the management of malaria. The product consists of blister packs of 6 tablets, box of 30 of lot number K U142 with an expiration date of January 2022 and blister packs of 12 tablets, box of 30 of lot number K U456 with an expiration date of January 2022.
The AL combination was administered at a dose of 4 mg artemether and 24 mg lumefantrine per kg for three days. The AL was provided by the NMCP.
The different prescriptions were as follows:
- 5 to 15 Kg: 1 tablet, twice a day for three days.
- 15 to 25 Kg: 2 tablets, twice a day for three days.
- 25 to 35 kg: 3 tablets, twice a day for three days.
- Over 35 kg: 4 tablets, twice a day for three days.
The first day's intake was done under direct observation and possible side effects were noted. Any patient who persistently vomited after taking the medication was excluded from the study and treated with artesunate. Patients were followed up regularly until Day 28 and received a clinical examination with thick drop control and axillary temperature taking at Day 0, Day 1, Day 2, Day 3, Day 7, Day 14, Day 21, and Day 28. Capillary blood on filtered paper (Wattman) was routinely collected from all patients on the day of inclusion ( Day 0) and during follow-up for molecular analysis. For follow-up, the density of asexual parasite forms was assessed on the basis of 8 000 leukocytes per microliter of blood. All slides were read by two microscopists to ensure control. At the end of the follow-up, the response to treatment was classified according to clinical and parasitological criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Model description
- This surveillance study is a prospective one-arm evaluation of clinical and parasitological responses to treatment of uncomplicated malaria with direct observation of treatment. Individuals with uncomplicated malaria, who meet the study inclusion criteria, will be recruited and treated at the sites by AL. They will be monitored for 28 days. Follow-up will consist of a series of fixed-date monitoring visits and corresponding clinical examinations and laboratory tests. Based on the results of these assessments, patients will be classified as having treatment failure (early or late) or adequate response. The proportion of patients with treatment failure during follow-up will be used to assess the efficacy of the study drugs. PCR analysis will be used to distinguish between true recrudescence due to treatment failure and episodes of re-infestation. A proportion of 10% of the slides read in the field will be submitted for quality control.
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Brachial circumference (BC) > 125 mm and P/T z-score > -2 Standard Deviation (SD)
- Age between three months and fifteen years,
- Monospecific Plasmodium falciparum infestation detected by microscopy;
- Parasitemia between 1000 and 200000 asexual parasitic forms/µl ;
- Axillary temperature ≥37.5° or history of fever in the past 24 hours ;
Key exclusion criteria (11 listed)
- Inability to take oral medications
- History of antimalarial treatment in the past two weeks, including sulfadoxine-pyrimethamine (SPAQ) for seasonal malaria chemoprevention (SMC)
- Lack of consent for pregnancy testing
- Presence of general danger signs in children under five years of age or signs of severe P. falciparum malaria as defined by World Health Organization (WHO);
- Mixed infestation or monospecific infestation with another Plasmodium species, detected by microscopic examination;
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 |
|---|---|---|
| Artemether-lumefantrineEfficacy of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sentinel sites in Niger (Agadez, Gaya and Tessaoua) in 2020 | Drug | – |
Primary outcome
Percentage of patients with asexual falciparum parasitaemia on Day 0.
Time frame: 4 weeks
Parasitaemia always refers to falciparum species. Mixed infections detected by light microscopy was excluded.
Number of patiants with presence of gametocytes on Day 0
Time frame: 4 weeks
Percentage of patients with danger signs of malaria on Day 1
Time frame: 4 weeks
Depending on the classification, a patient will be considered as having experienced treatment failure if the danger signs are associated with the presence of parasites.
Proportion of patients with 'adequate clinical and parasitological response' (ACPR) before PCR-corrected
Time frame: 8 weeks
absence of parasitaemia on day 28 (day 42), irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure
Proportion of patients with 'adequate clinical and parasitological response' (ACPR) after PCR-corrected
Time frame: 24 weeks
PCR analysis
Proportion of patients with 'early treatment failure' (ETF) before PCR-corrected
Time frame: 8 weeks
* Danger signs or severe malaria on day 1, 2 or 3, in the presence of parasitaemia; * Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; * Parasitaemia on day 3 with axillary temperature ≥ 37.5 °C; and * Parasitaemia on day 3 ≥ 25% of count on day 0
Proportion of patients with 'early treatment failure' (ETF) after PCR-corrected
Time frame: 24 weeks
-PCR analysis
Proportion of patients with 'late clinical failure' (LCF) before PCR-corrected
Time frame: 8 weeks
* danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 (day 42) in patients who did not previously meet any of the criteria of early treatment failure; and * presence of parasitaemia on any day between day 4 and day 28 (day 42) with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure
Proportion of patients with 'late clinical failure' (LCF) after PCR-corrected
Time frame: 24 weeks
PCR analysis
Proportion of patients with 'late parasitological failure' (LPF) before PCR-corrected
Time frame: 8 weeks
presence of parasitaemia on any day between day 7 and day 28 (day 42) with axillary temperature < 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.
Proportion of patients with 'late parasitological failure' (LPF) after PCR-corrected
Time frame: 24 weeks
PCR analysis
Percentage of the known mutations associated with artemisinin resistance observed.
Time frame: 24 weeks
PCR analysis
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 7 Oct 2021.
- Results publication: PubMed 11103309Severe falciparum malaria. World Health Organization, Communicable Diseases Cluster. Trans R Soc Trop Med Hyg. 2000 Apr;94 Suppl 1:S1-90. No abstract available.
- Derived from this study: PubMed 38741101Laminou IM, Issa I, Adehossi E, Maman K, Jackou H, Coulibaly E, Tohon ZB, Ahmed J, Sanoussi E, Koko D. Therapeutic efficacy and tolerability of artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria in Niger, 2020. Malar J. 2024 May 13;23(1):144. doi: 10.1186/s12936-024-04945-8.
- Individual participant dataSharing planned: Undecided. Data could be used for thesis
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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.
Hadiza JACKOU, Dr principal investigator
PROGRAMME NATIONAL DE LUTTE CONTRE LE PALUDISME
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 Artemether-lumefantrine in people with MALARIA, run by Programme National de Lutte contre le Paludisme, Niger at 1 site in Niger.
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 8 inclusion and 11 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 7 Oct 2021. 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 Niger. 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?
Percentage of patients with asexual falciparum parasitaemia on Day 0. (time frame: 4 weeks). The study lists 12 primary outcomes in all. 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 NCT05070520, which also lists 2 linked publications.
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 7 Oct 2021.