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

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

Study Overview

• Status: Completed
• Conditions: Schistosomiasis Haematobia
• Intervention / Treatment: Drug: Artesunate-Pyronaridine; Drug: Artemether-Lumefantrine; Drug: Artefenomel-Ferroquine

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Gabon
  • Lambaréné, Gabon, 242
    • Centre de Recherches Médicales de Lambaréné

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure Rate (CR)	CR of ACTs on Schistosoma haematobia	Day 28
Cure Rate (CR)	CR of ACTs on Schistosoma haematobia	Day 42

Collaborators and Investigators

• Sponsor: Centre de Recherche Médicale de Lambaréné
• Investigators: Principal Investigator: Rella Zoleko Manego, Centre de Recherches Medicales de Lambarene, Lambarene, Gabon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Helminthiasis; Urinary Tract Infections; Trematode Infections; Malaria; Coinfection; Schistosomiasis; Schistosomiasis haematobia; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anthelmintics; Schistosomicides; Antiplatyhelmintic Agents; Lumefantrine; Artemether; Artesunate; Artemether, Lumefantrine Drug Combination; Artefenomel; Ferroquine; Pyronaridine
• Other Study ID Numbers: CEI-006/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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