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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264130
Recruitment Status : Completed
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Centre de Recherche Médicale de Lambaréné

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 31, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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 Name: Pyramax

Drug: Artemether-Lumefantrine
subjects received artemether-lumefantrine according to their body weight twice per day for three days.
Other Name: 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




Primary Outcome Measures :
  1. Egg Reduction Rate (ERR) [ Time Frame: Day 28 ]
    Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia

  2. Egg Reduction Rate (ERR) [ Time Frame: Day 42 ]
    Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia


Secondary Outcome Measures :
  1. Cure Rate (CR) [ Time Frame: Day 28 ]
    CR of ACTs on Schistosoma haematobia

  2. Cure Rate (CR) [ Time Frame: Day 42 ]
    CR of ACTs on Schistosoma haematobia



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264130


Locations
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Gabon
Centre de Recherches Medicales de Lambarene
Lambaréné, Gabon, 242
Sponsors and Collaborators
Centre de Recherche Médicale de Lambaréné
Investigators
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Principal Investigator: Rella Zoleko Manego Centre de Recherches Medicales de Lambarene, Lambarene, Gabon
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Responsible Party: Centre de Recherche Médicale de Lambaréné
ClinicalTrials.gov Identifier: NCT04264130    
Other Study ID Numbers: CEI-006/2018
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Coinfection
Schistosomiasis haematobia
Malaria
Schistosomiasis
Infection
Protozoan Infections
Parasitic Diseases
Virus Diseases
Trematode Infections
Helminthiasis
Urinary Tract Infections
Urologic Diseases
Artesunate
Lumefantrine
Artemether
Artemether, Lumefantrine Drug Combination
Pyronaridine
Ferroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics