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

Sponsor

Centre de Recherche Médicale de Lambaréné (Other)

Overall Status

Completed

CT.gov ID

NCT04264130

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schistosomiasis Haematobia	Drug: Artesunate-Pyronaridine Drug: Artemether-Lumefantrine Drug: Artefenomel-Ferroquine	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 31, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: artemisinin-based combination therapies subjects given Artemisinin-based combined therapies according to the study instruction	Drug: Artesunate-Pyronaridine Subjects received artesunate-pyronaridine according to their body weight once per day for three days. Other Names: Pyramax Drug: Artemether-Lumefantrine subjects received artemether-lumefantrine according to their body weight twice per day for three days. Other Names: Coartem
Sham Comparator: non-artemisinin drugs subjects given non artemisinin based combined therapies like describe in the study protocol	Drug: Artefenomel-Ferroquine Subject received a single dose of artefenomel-ferroquine according to their body weight

Arm

Intervention/Treatment

Active Comparator: artemisinin-based combination therapies

subjects given Artemisinin-based combined therapies according to the study instruction

Drug: Artesunate-Pyronaridine

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

Other Names:

Pyramax

Drug: Artemether-Lumefantrine

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

Other Names:

Coartem

Sham Comparator: non-artemisinin drugs

subjects given non artemisinin based combined therapies like describe in the study protocol

Drug: Artefenomel-Ferroquine

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

Outcome Measures

Primary Outcome Measures

Egg Reduction Rate (ERR) [Day 28]
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Egg Reduction Rate (ERR) [Day 42]
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia

Secondary Outcome Measures

Cure Rate (CR) [Day 28]
CR of ACTs on Schistosoma haematobia
Cure Rate (CR) [Day 42]
CR of ACTs on Schistosoma haematobia

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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