NCT04264130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

February 6, 2020

Last Update Submit

February 7, 2020

Conditions

Schistosomiasis Haematobia

Outcome Measures

Primary Outcomes (2)

  • Egg Reduction Rate (ERR)

    Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia

    Day 28

  • Egg Reduction Rate (ERR)

    Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia

    Day 42

Secondary Outcomes (2)

  • Cure Rate (CR)

    Day 28

  • Cure Rate (CR)

    Day 42

Study Arms (2)

artemisinin-based combination therapies

ACTIVE COMPARATOR

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

Drug: Artesunate-PyronaridineDrug: Artemether-Lumefantrine

non-artemisinin drugs

SHAM COMPARATOR

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

Drug: Artefenomel-Ferroquine

Interventions

Artesunate-PyronaridineDRUG

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

Also known as: Pyramax
artemisinin-based combination therapies
Artemether-LumefantrineDRUG

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

Also known as: Coartem
artemisinin-based combination therapies
Artefenomel-FerroquineDRUG

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

non-artemisinin drugs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherches Medicales de Lambarene

Lambaréné, 242, Gabon

Location

Related Publications (1)

  • 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.

    PMID: 36315579DERIVED

MeSH Terms

Conditions

Schistosomiasis haematobia

Interventions

pyronaridine tetraphosphate, artesunate drug combinationArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

SchistosomiasisTrematode InfectionsHelminthiasisParasitic DiseasesInfectionsUrinary Tract InfectionsVector Borne DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Rella Zoleko Manego

    Centre de Recherches Medicales de Lambarene, Lambarene, Gabon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 11, 2020

Study Start

July 31, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GA(1)