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Effect of Artemisinin-based Combination Therapies on Schistosomiasis on Malaria Co-infection

Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04264130
Acronym
SACT
Enrollment
54
Registered
2020-02-11
Start date
2018-07-31
Completion date
2019-12-31
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis Haematobia

Brief 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. 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.

Interventions

Subjects received artesunate-pyronaridine according to their body weight once per day for three days.

DRUGArtemether-Lumefantrine

subjects received artemether-lumefantrine according to their body weight twice per day for three days.

DRUGArtefenomel-Ferroquine

Subject received a single dose of artefenomel-ferroquine according to their body weight

Sponsors

Centre de Recherche Médicale de Lambaréné
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patients treated with PZQ during the previous 6 weeks * Known intolerance /allergy to any study drug * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Egg Reduction Rate (ERR)Day 28Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia

Secondary

MeasureTime frameDescription
Cure Rate (CR)Day 28CR of ACTs on Schistosoma haematobia

Countries

Gabon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026