Malaria,FalciparumPhase 4NCT04565184
Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine for the Treatment of Malaria in Yaounde
A Phase 4 study testing Artesunate-amodiaquine combination and Artemether, Lumefantrine Drug Combination in people with Malaria,Falciparum, run by University of Yaounde 1 at 1 site in Cameroon.
Trial summary
Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict supervision of drug intake and limited to… Read more about this study
- Who is it for?
- Ages 6 to 120 months
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Artesunate-amodiaquine combination and Artemether, Lumefantrine Drug Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteCameroon
- Study dates
- 9 May 2019to 30 Nov 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 6 to 120 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either gender, aged 6 months to 120 months will be recruited.
- Acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density within the range 1000 to 200000 parasites/μl.
- Presenting with fever (axillary temperature ≥ 37.5oC) or having a history of fever in the preceding 24 hours.
- Able to ingest tablets orally (either suspended in water or uncrushed with food).
- Willing to participate in the study with written informed consent from parent/guardian.
- Willing and able to attend the clinic on stipulated regular follow-up visits.
Who cannot join
- Mixed with another Plasmodium species detected by microscopy.
- Children who are currently suffering or had the following within the last 2 months: tuberculosis, HIV, schistosomiasis, diabetes mellitus, cardiovascular disease, gout, rheumatoid arthritis, underlying chronic hepatic or renal disease, hypoglycaemia, jaundice, respiratory distress, and other inflammatory related diseases.
- Signs/symptoms indicating severe/complicated malaria" according to WHO criteria (WHO definition) such as:
- Not able to drink or breast feed. Persistent vomiting (>2 episodes within previous 24 hours). Convulsions (>1 episode within previous 24 hours). Lethargic/unconscious. Severe anaemia (haemoglobin < 5 g/dl).
- Serious gastrointestinal disease.
- Presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below -3 z-score (W/H < 70%) or has symmetrical edema involving at least the feet or has a mid-upper arm circumference < 115 mm).
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- Regular medication, which may interfere with anti-malarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to any of the medicine (s) being tested or used as alternative treatment (s).
- Individuals who have taken part in anti-malarial efficacy and safety studies in the last 3 months.
- Participants who have taken anti-malarial drugs in the last one month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring the Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine During the Treatment of Uncomplicated Plasmodium Falciparum Malaria Among Children in Yaounde, Cameroon
Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years of age are usually not involved in such studies. The main objective of this study is to assess the genetic markers of antimalarial drug resistance and drug metabolism subsequent to the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde, Cameroon. A randomized, open-labelled, controlled clinical trial comparing artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) will be carried out from 9th May 2019 to 30th November 2020 at two secondary health centres (Cité Verte and Minkoameyos) in Yaounde. The study participants shall include febrile patients aged 6 months to 10 years, with confirmed uncomplicated P. falciparum infection. Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1. A minimum sample of 76 patients will be required for the study. With a 20 % increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be enrolled for each of the two study arms. The study will recruit a total of 184 patients. Drug intake will be partially supervised only for the first dose and subsequent doses administered unsupervised as pertains in routine practice in the field. Patients or their parents/guardians will be advised on the time and mode of administration for the 3 days (D0, D1 and D2) treatment unobserved at home. Follow-up visits will be performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to differentiate between recrudescence and new infection.
Read the detailed description
Background: Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years of age are usually not involved in such studies.
Objective: To assess the genetic markers of antimalarial drug resistance and drug metabolism subsequent to the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde, Cameroon.
Study sites: District Hospital Cité Verte and District Medical Centre Minkoa Meyos in Yaounde, Cameroon. The two drugs, artesunate-amodiaquine and artemether-lumefantrine will be tested in each site.
Study period: 9th May 2019 to 30th November 2020.
Study design: This surveillance study is a two-arm, open-label, randomized controlled clinical trial.
Patient population: Febrile patients aged 6 months to 10 years, with confirmed uncomplicated P. falciparum infection. Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1.
Sample size: A minimum sample of 76 patients will be required for the study. With a 20 % increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be enrolled for each of the two study arms. The study will recruit a total of 184 patients.
Treatment (s) and follow-up: Drug intake will be partially supervised only for the first dose and subsequent doses administered unsupervised as pertains in routine practice in the field. Patients or their parents/guardians will be advised on the time and mode of administration for the 3 days (D0, D1 and D2) treatment unobserved at home. Follow-up visits will be performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to differentiate between recrudescence and new infection.
Classification of treatment outcomes Classification of treatment outcomes will be done based on the WHO 2009 guidelines: treatment failure (Early Treatment Failure-ETF, Late Clinical failure-LCF and Late Parasitological Failure-LPF) and treatment success (Adequate Clinical and Parasitological Response-ACPR).
- Conditions
- Malaria,Falciparum
- Being tested
- Artesunate-amodiaquine combination, Artemether, Lumefantrine Drug Combination
- Keywords
- Malaria, Plasmodium falciparum, Artesunate-amodiaquine, Artemether-lumefantrine, Effectiveness, Safety
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate-amodiaquine combinationDrug
Also called Coarsucam
Artesunate-amodiaquine (Coarsucam®: Sanofi-Aventis, France) is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight.
Artemether, Lumefantrine Drug CombinationDrug
Also called Coartem®
Artemether-lumefantrine (Coartem®: Novartis, Switzerland) is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child
| Study group | Role | What they receive |
|---|---|---|
| Artesunate-amodiaquine (Arm A) | Experimental | Artesunate-amodiaquine (Coarsucam®: Sanofi-Aventis, France) is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight. Receives: Drug: Artesunate-amodiaquine combination |
| Artemether-lumefantrine (Arm B) | Active comparator | Artemether-lumefantrine (Coartem®: Novartis, Switzerland) is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child. Receives: Drug: Artemether, Lumefantrine Drug Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment success and adverse events following treatment with artesunate-modiaquine and artemether-lumefantrine during 28 days follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde
Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) and follow-up will be done for a duration of 28 days.
Measured: 18 months
Secondary outcomes (4)
Proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy according to the WHO 2009 guidelines
Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) and follow-up will be done for a duration of 28 days. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis
Measured: 18 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) and follow-up will be done for a duration of 28 days.
Measured: 18 months
Number of children with single nucleotide polymorphisms of P. falciparum genes responsible for AS-AQ and AL resistance
Pre-treatment and recrudescence/reinfection samples during follow-up shall be used to characterize the molecular markers of Plasmodium falciparum chloroquine resistant transporter(Pfcrt), Plasmodium falciparum multi-drug resistant 1 (Pfmdr1), and Plasmodium falciparum K13 (Pfk13) propellar domain conferring resistance to artemisinins or partner drugs.
Measured: 18 months
Number of children haboring single nucleotide polymorphisms in key genes involved in the metabolism of AS-AQ and AL
Pre-treatment samples shall be used to characterize the human pharmacogenomic biomarkers (N-acetyl transferase 2-NAT2 and cytochrome P450: CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and CYP3A5)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start9 May 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
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 Malaria,FalciparumStudies 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
- Model description
- Eligible children for whom parent/guardian informed consent are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1.
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yaounde 1
- Sponsor type
- University, hospital or other
- Collaborators
- Malaria Research Capacity Development in West and Central Africa Consortium, Developing Excellence in Leadership, Training and Science Africa Initiative, Wellcome Trust, Department for International Development, United Kingdom
- Responsible party
- Principal investigator, Professor Wilfred Fon Mbacham, University of Yaounde 1
- Investigators
- Wilfred Fon Mbacham, PhD, Principal investigator, Biotechnology Centre, University of Yaounde I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565184
- Sponsor's protocol ID
- MARCAD/UYI/NPTN/12/16
- Status last verified
- Mar 2021
- First submitted
- 17 Sep 2020
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research findings will be communicated with the scientific community and policymakers. This will be done through public engagements and publications in peer-review journals.
Publications
Niba PTN, Nji AM, Ali IM, Akam LF, Dongmo CH, Chedjou JPK, Fomboh CT, Nana WD, Oben OLA, Selly-Ngaloumo AA, Moyeh MN, Ngu JA, Ludovic AJ, Aboh PM, Ambani MCE, Omgba PAM, Kotcholi GB, Adzemye LM, Nna DRA, Douanla A, Ango Z, Ewane MS, Ticha JT, Tatah FM, Dinza G, Ndikum VN, Fosah DA, Bigoga JD, Alifrangis M, Mbacham WF. Effectiveness and safety of artesunate-amodiaquine versus artemether-lumefantrine for home-based treatment of uncomplicated Plasmodium falciparum malaria among children 6-120 months in Yaounde, Cameroon: a randomized trial. BMC Infect Dis. 2022 Feb 21;22(1):166. doi: 10.1186/s12879-022-07101-2.
PubMed 35189818
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine During the Treatment of Uncomplicated Plasmodium Falciparum Malaria Among Children in Yaounde, Cameroon
- ClinicalTrials.gov ID
- NCT04565184
- Acronym / sponsor ID
- MARCAD/UYI/NPTN/12/16
- Conditions
- Malaria,Falciparum
- Keywords
- Malaria, Plasmodium falciparum, Artesunate-amodiaquine, Artemether-lumefantrine, Effectiveness, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of Yaounde 1University, hospital or other
- Collaborators
- Malaria Research Capacity Development in West and Central Africa Consortium, Developing Excellence in Leadership, Training and Science Africa Initiative, Wellcome Trust, Department for International Development, United Kingdom
- Study start
- 9 May 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 25 Sep 2020 (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.
Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years of age are usually not involved in such studies. The main objective of this study is to assess the genetic markers of antimalarial drug resistance and drug metabolism subsequent to the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde, Cameroon. A randomized, open-labelled, controlled clinical trial comparing artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) will be carried out from 9th May 2019 to 30th November 2020 at two secondary health centres (Cité Verte and Minkoameyos) in Yaounde. The study participants shall include febrile patients aged 6 months to 10 years, with confirmed uncomplicated P. falciparum infection. Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1. A minimum sample of 76 patients will be required for the study. With a 20 % increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be enrolled for each of the two study arms. The study will recruit a total of 184 patients. Drug intake will be partially supervised only for the first dose and subsequent doses administered unsupervised as pertains in routine practice in the field. Patients or their parents/guardians will be advised on the time and mode of administration for the 3 days (D0, D1 and D2) treatment unobserved at home. Follow-up visits will be performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to differentiate between recrudescence and new infection.
Detailed description
Background: Artesunate-amodiaquine and artemether-lumfantrine are currently being used for the treatment of uncomplicated Plasmodium falciparum in Cameroon. Globally, many studies have reported high efficacy and safety of artemisinin-based combination therapies (ACTs) mostly under strict supervision of drug intake and limited to children less than 5 years of age. Patients over 5 years of age are usually not involved in such studies.
Objective: To assess the genetic markers of antimalarial drug resistance and drug metabolism subsequent to the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine during a 28-day follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde, Cameroon.
Study sites: District Hospital Cité Verte and District Medical Centre Minkoa Meyos in Yaounde, Cameroon. The two drugs, artesunate-amodiaquine and artemether-lumefantrine will be tested in each site.
Study period: 9th May 2019 to 30th November 2020.
Study design: This surveillance study is a two-arm, open-label, randomized controlled clinical trial.
Patient population: Febrile patients aged 6 months to 10 years, with confirmed uncomplicated P. falciparum infection. Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1.
Sample size: A minimum sample of 76 patients will be required for the study. With a 20 % increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 92 patients will be enrolled for each of the two study arms. The study will recruit a total of 184 patients.
Treatment (s) and follow-up: Drug intake will be partially supervised only for the first dose and subsequent doses administered unsupervised as pertains in routine practice in the field. Patients or their parents/guardians will be advised on the time and mode of administration for the 3 days (D0, D1 and D2) treatment unobserved at home. Follow-up visits will be performed on days 3, 7, 14, 21, and 28 to evaluate clinical and parasitological resolution of their malaria episode as well as adverse events. Polymerase chain reaction (PCR) genotyping of merozoite surface proteins 1 and 2 (msp-1, msp-2) as well as glutamate rich protein (GLURP) will be used to differentiate between recrudescence and new infection.
Classification of treatment outcomes Classification of treatment outcomes will be done based on the WHO 2009 guidelines: treatment failure (Early Treatment Failure-ETF, Late Clinical failure-LCF and Late Parasitological Failure-LPF) and treatment success (Adequate Clinical and Parasitological Response-ACPR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible children for whom parent/guardian informed consent are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) in the ratio 1:1.
| Arm | Type | Receives |
|---|---|---|
| Artesunate-amodiaquine (Arm A) | Experimental | Drug: Artesunate-amodiaquine combinationArtesunate-amodiaquine (Coarsucam®: Sanofi-Aventis, France) is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight. |
| Artemether-lumefantrine (Arm B) | Active comparator | Drug: Artemether, Lumefantrine Drug CombinationArtemether-lumefantrine (Coartem®: Novartis, Switzerland) is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child. |
Who may qualify
- Ages
- 6 to 120 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children of either gender, aged 6 months to 120 months will be recruited.
- Acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density within the range 1000 to 200000 parasites/μl.
- Presenting with fever (axillary temperature ≥ 37.5oC) or having a history of fever in the preceding 24 hours.
- Able to ingest tablets orally (either suspended in water or uncrushed with food).
- Willing to participate in the study with written informed consent from parent/guardian.
Key exclusion criteria (10 listed)
- Mixed with another Plasmodium species detected by microscopy.
- Children who are currently suffering or had the following within the last 2 months: tuberculosis, HIV, schistosomiasis, diabetes mellitus, cardiovascular disease, gout, rheumatoid arthritis, underlying chronic hepatic or renal disease, hypoglycaemia, jaundice, respiratory distress, and other inflammatory related diseases.
- Signs/symptoms indicating severe/complicated malaria" according to WHO criteria (WHO definition) such as:
- Not able to drink or breast feed. Persistent vomiting (>2 episodes within previous 24 hours). Convulsions (>1 episode within previous 24 hours). Lethargic/unconscious. Severe anaemia (haemoglobin < 5 g/dl).
- Serious gastrointestinal disease.
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 |
|---|---|---|
| Artesunate-amodiaquine combinationAlso: CoarsucamArtesunate-amodiaquine (Coarsucam®: Sanofi-Aventis, France) is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight. | Drug | Artesunate-amodiaquine (Arm A) |
| Artemether, Lumefantrine Drug CombinationAlso: Coartem®Artemether-lumefantrine (Coartem®: Novartis, Switzerland) is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child | Drug | Artemether-lumefantrine (Arm B) |
Primary outcome
Number of participants with treatment success and adverse events following treatment with artesunate-modiaquine and artemether-lumefantrine during 28 days follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde
Time frame: 18 months
Eligible children for whom parent/guardian informed consents are obtained will be randomized to receive either artesunate-amodiaquine (group A) or artemether-lumefantrine (group B) and follow-up will be done for a duration of 28 days.
4 secondary outcomes
Proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy according to the WHO 2009 guidelines
Time frame: 18 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 18 months
Number of children with single nucleotide polymorphisms of P. falciparum genes responsible for AS-AQ and AL resistance
Time frame: 18 months
Number of children haboring single nucleotide polymorphisms in key genes involved in the metabolism of AS-AQ and AL
Time frame: 18 months
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 2 Apr 2021.
- Derived from this study: PubMed 35189818Niba PTN, Nji AM, Ali IM, Akam LF, Dongmo CH, Chedjou JPK, Fomboh CT, Nana WD, Oben OLA, Selly-Ngaloumo AA, Moyeh MN, Ngu JA, Ludovic AJ, Aboh PM, Ambani MCE, Omgba PAM, Kotcholi GB, Adzemye LM, Nna DRA, Douanla A, Ango Z, Ewane MS, Ticha JT, Tatah FM, Dinza G, Ndikum VN, Fosah DA, Bigoga JD, Alifrangis M, Mbacham WF. Effectiveness and safety of artesunate-amodiaquine versus artemether-lumefantrine for home-based treatment of uncomplicated Plasmodium falciparum malaria among children 6-120 months in Yaounde, Cameroon: a randomized trial. BMC Infect Dis. 2022 Feb 21;22(1):166. doi: 10.1186/s12879-022-07101-2.
- Individual participant dataSharing planned: Yes. Research findings will be communicated with the scientific community and policymakers. This will be done through public engagements and publications in peer-review journals.
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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.
Wilfred Fon Mbacham, PhD principal investigator
Biotechnology Centre, University of Yaounde I
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 Artesunate-amodiaquine combination and Artemether, Lumefantrine Drug Combination in people with Malaria,Falciparum, run by University of Yaounde 1 at 1 site in Cameroon.
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 10 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 2 Apr 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 Cameroon. 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?
Number of participants with treatment success and adverse events following treatment with artesunate-modiaquine and artemether-lumefantrine during 28 days follow-up period in children with acute uncomplicated P. falciparum malaria in Yaounde (time frame: 18 months). 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 NCT04565184, 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 2 Apr 2021.