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Completed

NCT Number: NCT04264130

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

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.

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Key information

Conditions

Schistosomiasis Haematobia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Helminthiasis Infections Male Urogenital Diseases Parasitic Diseases Schistosomiasis Trematode Infections Urinary Tract Infections Urogenital Diseases Urologic Diseases Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre de Recherches Medicales de Lambarene

Lambaréné, 242, Gabon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate-Pyronaridine

Drug

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

Other names: Pyramax

Artemether-lumefantrine

Drug

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

Other names: Coartem

Artefenomel-Ferroquine

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre de Recherche Médicale de Lambaréné

Other

Registry information

Official study title

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

Acronym: SACT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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