Schistosomiasis HaematobiaPhase 2SACTNCT04264130
Effect of Artemisinin-based Combination Therapies on Schistosomiasis on Malaria Co-infection
A Phase 2 study testing Artesunate-Pyronaridine, Artemether-Lumefantrine and Artefenomel-Ferroquine in people with Schistosomiasis Haematobia, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
Trial summary
Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schistosomiasis Haematobia
- What is being tested?
- Artesunate-Pyronaridine, Artemether-Lumefantrine and Artefenomel-Ferroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGabon
- Study dates
- 31 Jul 2018to 31 Dec 2019
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Malaria infection diagnosed by Rapid Diagnostic Tests (RDTs) or thick blood smear
- Urinary schistosomiasis diagnosed by presence of Schistosoma haematobium eggs in the urine before malaria treatment
- Written informed consent
Who cannot join
- Patients treated with PZQ during the previous 6 weeks
- Known intolerance /allergy to any study drug
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection
Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.
Read the detailed description
Study population included all subjects in study area who signed a written Informed Consent Form diagnosed with Malaria- STS co-infection. Those excluded were treated with PZQ prior 6 weeks, have drug intolerance or pregnant. At Inclusion, Basic Demographic data was recorded and urine samples analysed. During the follow up visits, urine samples were collected on D28 and D42 (6 weeks post treatment). Post treatment assessment was done on urine samples collected on at least two consecutive days and at the end of follow up, all subjects were treated with a single dose pf PZQ (40 mg/kg) as recommended by WHO.
- Conditions
- Schistosomiasis Haematobia
- Being tested
- Artesunate-Pyronaridine, Artemether-Lumefantrine, Artefenomel-Ferroquine
- Medical subject headings
- Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate-PyronaridineDrug
Also called Pyramax
Subjects received artesunate-pyronaridine according to their body weight once per day for three days.
Artemether-LumefantrineDrug
Also called Coartem
subjects received artemether-lumefantrine according to their body weight twice per day for three days.
Artefenomel-FerroquineDrug
Subject received a single dose of artefenomel-ferroquine according to their body weight
| Study group | Role | What they receive |
|---|---|---|
| artemisinin-based combination therapies | Active comparator | subjects given Artemisinin-based combined therapies according to the study instruction Receives: Drug: Artesunate-Pyronaridine; Drug: Artemether-Lumefantrine |
| non-artemisinin drugs | Sham comparator | subjects given non artemisinin based combined therapies like describe in the study protocol Receives: Drug: Artefenomel-Ferroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Egg Reduction Rate (ERR)
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Measured: Day 28
Egg Reduction Rate (ERR)
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Measured: Day 42
Secondary outcomes (2)
Cure Rate (CR)
CR of ACTs on Schistosoma haematobia
Measured: Day 28
Cure Rate (CR)
CR of ACTs on Schistosoma haematobia
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 posted11 Feb 2020
- Study start31 Jul 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Schistosomiasis HaematobiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rella Zoleko Manego, Principal investigator, Centre de Recherches Medicales de Lambarene, Lambarene, Gabon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264130
- Sponsor's protocol ID
- CEI-006/2018
- Acronym
- SACT
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zoleko-Manego R, Okwu DG, Handrich C, Dimessa-Mbadinga LB, Akinosho MA, Ndzebe-Ndoumba WF, Davi SD, Stelzl D, Veletzky L, Kreidenweiss A, Nordmann T, Adegnika AA, Lell B, Kremsner PG, Ramharter M, Mombo-Ngoma G. Effectiveness of antimalarial drug combinations in treating concomitant urogenital schistosomiasis in malaria patients in Lambarene, Gabon: A non-randomised event-monitoring study. PLoS Negl Trop Dis. 2022 Oct 31;16(10):e0010899. doi: 10.1371/journal.pntd.0010899. eCollection 2022 Oct.
PubMed 36315579
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection
- ClinicalTrials.gov ID
- NCT04264130
- Acronym / sponsor ID
- SACT / CEI-006/2018
- Conditions
- Schistosomiasis Haematobia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Feb 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.
Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.
Detailed description
Study population included all subjects in study area who signed a written Informed Consent Form diagnosed with Malaria- STS co-infection. Those excluded were treated with PZQ prior 6 weeks, have drug intolerance or pregnant. At Inclusion, Basic Demographic data was recorded and urine samples analysed. During the follow up visits, urine samples were collected on D28 and D42 (6 weeks post treatment). Post treatment assessment was done on urine samples collected on at least two consecutive days and at the end of follow up, all subjects were treated with a single dose pf PZQ (40 mg/kg) as recommended by WHO.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artemisinin-based combination therapies | Active comparator | Drug: Artesunate-Pyronaridine, Drug: Artemether-Lumefantrinesubjects given Artemisinin-based combined therapies according to the study instruction |
| non-artemisinin drugs | Sham comparator | Drug: Artefenomel-Ferroquinesubjects given non artemisinin based combined therapies like describe in the study protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Malaria infection diagnosed by Rapid Diagnostic Tests (RDTs) or thick blood smear
- Urinary schistosomiasis diagnosed by presence of Schistosoma haematobium eggs in the urine before malaria treatment
- Written informed consent
Key exclusion criteria (3 listed)
- Patients treated with PZQ during the previous 6 weeks
- Known intolerance /allergy to any study drug
- Pregnancy
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-PyronaridineAlso: PyramaxSubjects received artesunate-pyronaridine according to their body weight once per day for three days. | Drug | artemisinin-based combination therapies |
| Artemether-LumefantrineAlso: Coartemsubjects received artemether-lumefantrine according to their body weight twice per day for three days. | Drug | artemisinin-based combination therapies |
| Artefenomel-FerroquineSubject received a single dose of artefenomel-ferroquine according to their body weight | Drug | non-artemisinin drugs |
Primary outcome
Egg Reduction Rate (ERR)
Time frame: Day 28
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Egg Reduction Rate (ERR)
Time frame: Day 42
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
2 secondary outcomes
Cure Rate (CR)
Time frame: Day 28
Cure Rate (CR)
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 11 Feb 2020.
- Derived from this study: PubMed 36315579Zoleko-Manego R, Okwu DG, Handrich C, Dimessa-Mbadinga LB, Akinosho MA, Ndzebe-Ndoumba WF, Davi SD, Stelzl D, Veletzky L, Kreidenweiss A, Nordmann T, Adegnika AA, Lell B, Kremsner PG, Ramharter M, Mombo-Ngoma G. Effectiveness of antimalarial drug combinations in treating concomitant urogenital schistosomiasis in malaria patients in Lambarene, Gabon: A non-randomised event-monitoring study. PLoS Negl Trop Dis. 2022 Oct 31;16(10):e0010899. doi: 10.1371/journal.pntd.0010899. eCollection 2022 Oct.
- Individual participant dataSharing planned: No
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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.
Rella Zoleko Manego principal investigator
Centre de Recherches Medicales de Lambarene, Lambarene, Gabon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate-Pyronaridine, Artemether-Lumefantrine and Artefenomel-Ferroquine in people with Schistosomiasis Haematobia, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
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 3 inclusion and 3 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 Feb 2020. 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 Gabon. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Egg Reduction Rate (ERR) (time frame: Day 28). The study lists 2 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 NCT04264130, 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 Feb 2020.