Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study

NCT04115072 | Completed Phase 2

• 1 other identifier: RHN_PCL_01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Female genital schistosomiasis (FGS) is a frequent manifestation of the infection with Schistosoma haematobium or mansoni. FGS is probably the most neglected gynaecological condition in the tropics. Inflammation of genital tissue persists as long as adult worms are present in the circulation, and new eggs are released. Hence, lesions can only heal if the inflammation is abated and a normal immune response is restored A randomized controlled study will be carried out to compare the efficacy of the standard treatment with that of five repeated doses of praziquantel. Outcome measure is the disappearance/regression of clinical pathology at the cervix, in the vagina/vulva.

Conditions

Schistosomiasis

Keywords

Schistosomiasis; Praziquantel; Gynaecology; Female

Outcome Measures

Primary Outcomes (1)

• Pathognomonic sign(s) in the cervix

  Changes is quantitatively measured by the comparison of the number of sectors of the cervix affected by a pathognomonic sign before treatment and at the end of the study.

  15 weeks

Secondary Outcomes (5)

• Gynaecological complaint score

  15 weeks

• Vaginal Schistosome DNA

  15 weeks

• Vaginal Pro-inflammatory Th2-dependent cytokines /chemokines

  15 weeks

• Vaginal ECP

  15 weeks

• Cytobrush Schistosome DNA

  15 weeks

Study Arms (2)

A - Single dose og PZQ

ACTIVE COMPARATOR

Single dose of Praziquantel 40 mg/kg Standard treatment of schistosomiasis as recommended by WHO

Drug: Praziquantel 600Mg Oral Tablet x 1

B - Five doses of PZQ

EXPERIMENTAL

Five doses of Praziquantel 1 x 40 mg/kg Praziquantel after enrollment in the study plus two single doses (40 mg/kg) after 12 and 24 hours after the first treatment 1 x 40 mg/kg Praziquantel five weeks following the 1st dose 1 x 40 mg/kg Praziquantel ten weeks following the 1st dose

Drug: Praziquantel 600Mg Oral Tablet x 5

Interventions

Praziquantel 600Mg Oral Tablet x 5 DRUG

Five doses of Praziquantel 40 mg/kg

Also known as: PZQ

B - Five doses of PZQ

Praziquantel 600Mg Oral Tablet x 1 DRUG

Single dose of Praziquantel 40 mg/kg

Also known as: PZQ

A - Single dose og PZQ

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women 15 to 35 years of age with a gynaecological/urinary/lower abdominal complaint
• The woman has signed the informed consent form (IFC); in the case of minors, the IFC has to be signed by parent or guardian.
• The woman does not plan to leave the area within 6 months and accept to come to the CSB regularly following the scheduled follow-up (at week 5,10 and 15).
• The woman with confirmed diagnosed of FGS (as described in section 6.3.1)
• The woman agrees to be examined clinically and gynaecologically including taking specimens from the genital tract (collection of vaginal lavage fluid, collection of cells with a cytobrush).
• The woman agrees to provide a urine and a stool sample.
• The woman agrees that a venous blood sample for laboratory assessments is taken.
• The woman accepts to stay at the hospital for 2 days follow-up after the first dose of PZQ.

You may not qualify if:

• Virgin (assessed by gynaecologist)
• Pregnancy (determined by pregnancy test)
• Tumor of vulva, vagina, uterus (diagnosed by gynaecologist)
• Treatment with praziquantel during the last 3 months
• Hysterectomy
• Known HIV positive prior to enrollment
• Any severe medical condition requiring hospitalization
• The woman is unable to comprehend the nature and objectives of the study
• The woman is judged by the investigators to be unlikely to participate regularly in the follow-up
• The woman is taking any drug that might affect the metabolism of PZQ and that is contraindicated the last two weeks before the enrollment. These drugs are as follows: rifampin; phenytoin, carbamazepine, phenobarbital; dexamethasone;
• The woman is taking a drug which decreases the activity of praziquantel metabolizing enzymes (P450 inhibitors) the last two weeks before the enrollment, for example cimetidine, ketoconazole, itraconazole, erythromycin.
• All contraindications to Praziquantel

Sponsors & Collaborators

• Regionshospital Nordjylland: lead
• Charite University, Berlin, Germany: collaborator
• Leiden University Medical Center: collaborator
• Nagasaki University: collaborator
• Umeå University: collaborator
• Merck Serono International SA: collaborator
• Ministry of Health, Madagascar: collaborator

Study Sites (1)

K'Olo Vanona

Ambanja, Diana Region, 203, Madagascar

Location

Related Publications (2)

• Schuster A, Randrianasolo BS, Rabozakandraina OO, Ramarokoto CE, Bronnum D, Feldmeier H. Knowledge, experiences, and practices of women affected by female genital schistosomiasis in rural Madagascar: A qualitative study on disease perception, health impairment and social impact. PLoS Negl Trop Dis. 2022 Nov 7;16(11):e0010901. doi: 10.1371/journal.pntd.0010901. eCollection 2022 Nov.

  PMID: 36342912 DERIVED

• Arenholt LTS, Aaroe KK, Norderud K, Lumholdt M, Randrianasolo BS, Ramarokoto CE, Rabozakandraina O, Broennum D, Feldmeier H, Leutscher PDC. Cervical lesion proportion measure using a digital gridded imaging technique to assess cervical pathology in women with genital schistosomiasis. PLoS Negl Trop Dis. 2022 Jul 5;16(7):e0009995. doi: 10.1371/journal.pntd.0009995. eCollection 2022 Jul.

  PMID: 35788749 DERIVED

MeSH Terms

Conditions

Schistosomiasis

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter Leutscher, PhD

  Centre for Clinical Research, North Denmark Regional Hospital, Denmark

  STUDY DIRECTOR

• Bodo S Randrianasolo, MD

  K'OLO VANONA; Antananarivo, Madagascar

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: October 3, 2019
• Study Start: September 3, 2019
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)