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

Primary Purpose

Schistosomiasis Haematobia

Status
Completed
Phase
Phase 2
Locations
Gabon
Study Type
Interventional
Intervention
Artesunate-Pyronaridine
Artemether-Lumefantrine
Artefenomel-Ferroquine
Sponsored by
Centre de Recherche Médicale de Lambaréné
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schistosomiasis Haematobia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • Centre de Recherches Medicales de Lambarene

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

artemisinin-based combination therapies

non-artemisinin drugs

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cure Rate (CR)
CR of ACTs on Schistosoma haematobia
Cure Rate (CR)
CR of ACTs on Schistosoma haematobia

Full Information

First Posted
February 6, 2020
Last Updated
February 7, 2020
Sponsor
Centre de Recherche Médicale de Lambaréné
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1. Study Identification

Unique Protocol Identification Number
NCT04264130
Brief Title
Effect of Artemisinin-based Combination Therapies on Schistosomiasis on Malaria Co-infection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre de Recherche Médicale de Lambaréné

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis Haematobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artemisinin-based combination therapies
Arm Type
Active Comparator
Arm Description
subjects given Artemisinin-based combined therapies according to the study instruction
Arm Title
non-artemisinin drugs
Arm Type
Sham Comparator
Arm Description
subjects given non artemisinin based combined therapies like describe in the study protocol
Intervention Type
Drug
Intervention Name(s)
Artesunate-Pyronaridine
Other Intervention Name(s)
Pyramax
Intervention Description
Subjects received artesunate-pyronaridine according to their body weight once per day for three days.
Intervention Type
Drug
Intervention Name(s)
Artemether-Lumefantrine
Other Intervention Name(s)
Coartem
Intervention Description
subjects received artemether-lumefantrine according to their body weight twice per day for three days.
Intervention Type
Drug
Intervention Name(s)
Artefenomel-Ferroquine
Intervention Description
Subject received a single dose of artefenomel-ferroquine according to their body weight
Primary Outcome Measure Information:
Title
Egg Reduction Rate (ERR)
Description
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Time Frame
Day 28
Title
Egg Reduction Rate (ERR)
Description
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
Cure Rate (CR)
Description
CR of ACTs on Schistosoma haematobia
Time Frame
Day 28
Title
Cure Rate (CR)
Description
CR of ACTs on Schistosoma haematobia
Time Frame
Day 42

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rella Zoleko Manego
Organizational Affiliation
Centre de Recherches Medicales de Lambarene, Lambarene, Gabon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherches Medicales de Lambarene
City
Lambaréné
ZIP/Postal Code
242
Country
Gabon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36315579
Citation
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.
Results Reference
derived

Learn more about this trial

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

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