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SchistosomiasisPhase 2/3NCT04115072

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

A Phase 2/3 study testing Praziquantel 600Mg Oral Tablet x 5 and Praziquantel 600Mg Oral Tablet x 1 in people with Schistosomiasis, run by Regionshospital Nordjylland at 1 site in Madagascar.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Schistosomiasis
What is being tested?
Praziquantel 600Mg Oral Tablet x 5 and Praziquantel 600Mg Oral Tablet x 1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteMadagascar
Study dates
3 Sep 2019to 21 Feb 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Madagascar1 site

  • K'Olo Vanona

    Ambanja, Diana Region, 203

Other trials in Madagascar

About this study

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.

Read the detailed description

Female genital schistosomiasis (FGS) is a frequent manifestation of the infection with Schistosoma haematobium or mansoni. It occurs in women of all age groups, including young girls and is associated with important, frequently debilitating and stigmatizing morbidity. It may develop into a life-threatening condition. FGS is probably the most neglected gynaecological condition in the tropics.

Depending on where eggs are released the clinical pathology develops in vulva and vagina, cervix, uterus, Fallopian tubes and the ovaries. All genital organs may be affected simultaneously. Women with FGS report spontaneous, or post-coital bleeding, vaginal discharge, pain during sexual intercourse, pelvic pain, irregular menstruation and infertility. Vaginal discharge and itching, pain during sexual intercourse, spontaneous + post-coital bleeding, as well as menstruation abnormalities are attributed by the women to STIs. This results in shame, mental strain and distress, eventually causes stigmatization and social exclusion leading to an impaired life quality.

Clinical, histopathological, immunological and epidemiological evidence suggests that there is a cause-effect relationship between FGS and HIV infection. There are hints of a cause effect relationship between FGS and HPV. The association of FGS with HIV /HPV infection underlines the pivotal importance for an effective treatment of FGS.

Clinical pathology is the result of a complex inflammatory response to antigens released by adult worms and viable eggs. The inflammation of genital tissue persists as long as adult worms are present in the circulation, and new eggs are released and become trapped. Hence, lesions can only heal if the inflammation is abated and a normal immune response is restored. This means that all worms have to be eliminated and reinfection has to be prevented for some time to allow complete healing of genital organs.

Based on this rationale, five doses of praziquantel will be given over a period of 10 weeks to ensure that all existing worms will be eliminated. The first three doses aim to kill all adult worms. The fourth dose will kill schistosomula which will mature in the following weeks. The last dose will prevent women from re-infection.

A randomized controlled study will be carried out to compare the efficacy of the standard treatment with that of repeated doses of praziquantel. Since a placebo is not available, the study will not be blinded. Outcome measure is the disappearance/regression of clinical pathology at the cervix, in the vagina/vulva.

The result of this study has important implications for the sexual health of millions of women in sub-Saharan Africa.

The aim of the study is to compare standard treatment of schistosomiasis as recommended by WHO (a single dose of praziquantel 40 mg/kg)- with a treatment based on a new rationale: five doses of praziquantel 40 mg/kg

  • 1 x 40 mg/kg after enrollment in the study (D1, H0) plus two single doses (40 mg/kg) after 12 and 24 hours after the first treatment
  • 1 x 40 mg/kg five weeks following the 1st PZQ treatment
  • 1 x 40 mg/kg ten weeks following the 1st PZQ treatment
Conditions
Schistosomiasis
Being tested
Praziquantel 600Mg Oral Tablet x 5, Praziquantel 600Mg Oral Tablet x 1
Keywords
Schistosomiasis, Praziquantel, Gynaecology, Female
Medical subject headings
Schistosomiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Praziquantel 600Mg Oral Tablet x 5Drug

    Also called PZQ

    Five doses of Praziquantel 40 mg/kg

  • Praziquantel 600Mg Oral Tablet x 1Drug

    Also called PZQ

    Single dose of Praziquantel 40 mg/kg

Study groups in NCT04115072
Study groupRoleWhat they receive
A - Single dose og PZQActive comparatorSingle dose of Praziquantel 40 mg/kg Standard treatment of schistosomiasis as recommended by WHO
Receives: Drug: Praziquantel 600Mg Oral Tablet x 1
B - Five doses of PZQExperimentalFive 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
Receives: Drug: Praziquantel 600Mg Oral Tablet x 5

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 weeks

Secondary outcomes (5)

  1. Gynaecological complaint score

    Gynaecologial symptoms assessed by a questionnaire (Lower abdominal pain, Itching of vagina/vulva, Vaginal discharge with a strange odor, Pain/abnormal sensation during sexual intercourse, Bleeding after sexual intercourse, Abnormal sensation when touching vulva/vagina, Spontaneous bleeding (outside menstruation), Irregular menstruation, Infertility (primary or secondary) after two years without contraception, Pain during micturition, Blood in urine outside menstruation).

    Measured: 15 weeks

  2. Vaginal Schistosome DNA

    Concentration of schistosome DNA in vaginal fluid

    Measured: 15 weeks

  3. Vaginal Pro-inflammatory Th2-dependent cytokines /chemokines

    Concentration of selected pro-inflammatory Th2-dependent cytokines /chemokines in vaginal fluid

    Measured: 15 weeks

  4. Vaginal ECP

    Eosinophilic cationic protein (ECP) in vaginal lavage fluid

    Measured: 15 weeks

  5. Cytobrush Schistosome DNA

    Concentration of schistosome DNA in cytobrush material from vagina

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2019
  2. Study start3 Sep 2019
  3. Primary completion21 Feb 2020
  4. Study completion21 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04115072
Sponsor's protocol ID
RHN_PCL_01
Status last verified
May 2020
First submitted
22 Aug 2019
Last updated
18 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36342912

  • 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.

    PubMed 35788749

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Praziquantel 600Mg Oral Tablet x 5 and Praziquantel 600Mg Oral Tablet x 1 in people with Schistosomiasis, run by Regionshospital Nordjylland at 1 site in Madagascar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathognomonic sign(s) in the cervix (time frame: 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04115072, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.

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