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

Schistosomiasis Haematobia Clinical Trial

— SACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264130
• Other study ID #: CEI-006/2018
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Centre de Recherche Médicale de Lambaréné
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coinfection
• Malaria
• Schistosomiasis
• Schistosomiasis haematobia

Intervention

Drug:
• Artesunate-Pyronaridine
Subjects received artesunate-pyronaridine according to their body weight once per day for three days.
• Artemether-Lumefantrine
subjects received artemether-lumefantrine according to their body weight twice per day for three days.
• Artefenomel-Ferroquine
Subject received a single dose of artefenomel-ferroquine according to their body weight

Locations

Country	Name	City	State
Gabon	Centre de Recherches Medicales de Lambarene	Lambaréné

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche Médicale de Lambaréné

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Egg Reduction Rate (ERR)	Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia	Day 28
Primary	Egg Reduction Rate (ERR)	Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia	Day 42
Secondary	Cure Rate (CR)	CR of ACTs on Schistosoma haematobia	Day 28
Secondary	Cure Rate (CR)	CR of ACTs on Schistosoma haematobia	Day 42