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SchistosomiasisPhase 4NCT02734186

Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in People With Schistosomiasis

A Phase 4 study testing Praziquantel in people with Schistosomiasis, run by National Institute of Allergy and Infectious Diseases (NIAID).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Background: Schistosomiasis is a chronic infection. It is caused by parasitic worms called Schistosoma haematobium (Sh) that are spread by snails that live in rivers. It can lead to liver problems or bladder cancer. Praziquantel (PZQ) is a drug used to treat this infection. Read more about this study

Who is it for?
Ages 14 to 80 years
Conditions the study is for
Schistosomiasis
What is being tested?
Praziquantel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
6 Apr 2016to 14 Dec 2018
Phase
Phase 4
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 14 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or non-pregnant female subjects
  • Age 14-80 years (per participant self-report)
  • Resident of Tienegubougou, Bougoudiana or surrounding villages
  • 5. Consent to a blood draw to screen for filarial infection and a urine exam to screen for schistosomiasis
  • 6. Must be willing to have blood samples stored.
  • S. haematobium infection documented at screening and within 14 days prior to the baseline visit
  • The subject agrees to storage of samples for study.

Who cannot join

  • Known to be pregnant (by history)
  • Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant
  • History of hypersensitivity reaction to PZQ.
  • Weight less than 20 kg
  • Pregnancy (by urine beta-HCG)
  • Chronic kidney or liver disease
Show all 16Show fewer
  • Hgb <10 mg/dL
  • PZQ treatment since the screening visit
  • Concomitant Schistosoma mansoni, Wuchereria bancrofti (Wb) or Onchocerca volvulus infection
  • Use of immunosuppressive therapies, including steroids, within the past month
  • Any condition that in the investigator s opinion places the subject at undue risk by participating in the study.
  • Pregnant women will be excluded from this study since it involves administration of medications contraindicated in pregnancy. Children less than 14 years old will be excluded because of the amount of blood required for the immunologic studies. The age of consent in Mali is 18 years of age, so children aged 14 to 17 years will sign an assent form in addition to the consent form to be signed by a parent or tutor. However, married women between the ages of 14 and 17 will sign consent as adults in view of the laws governing emancipation of women in Mali. Subjects who do not participate in this study will receive PZQ as part of the national schistosomiasis control program.
  • Participation of Women:
  • -Pregnancy: The effects of praziquantel on the developing human fetus are unknown (pregnancy category B). For this reason, females of
  • childbearing-age must have a negative pregnancy test result prior to receiving praziquantel. Since the half-life of praziquantel is short (3-4 hours), contraceptive measures will not be required post-treatment.
  • -Breast feeding: Praziquantel is known to be present in breast milk for up to 3 days following a single dose and is not approved for use in children under the age of 4 years. Consequently, women will be asked to suspend breastfeeding after treatment with PZQ for 3 days. Formula will be provided for breastfed children affected by their mother s participation during this time to ensure adequate nutrition. Depending on the age of the child, formula may be given. A pediatric nurse will be present during this time to provide assistance and counsel to the mothers.

About this study

Official title: Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in Subjects With Schistosomiasis: A Pilot Study

Background:

Schistosomiasis is a chronic infection. It is caused by parasitic worms called Schistosoma haematobium (Sh) that are spread by snails that live in rivers. It can lead to liver problems or bladder cancer. Praziquantel (PZQ) is a drug used to treat this infection. After taking it, some people develop increased resistance to reinfection with Sh. Some people with Sh infection can be infected with another worm called Mansonella perstans (Mp). Mp is spread through a biting insect called a midge. It rarely causes symptoms. However, researchers think that Mp infection could affect the body s response to PZQ treatment for or risk of reinfection with Sh.

Read more

Objective:

To find out the effects of Mp infection on the response to PZQ treatment for Sh infection.

Eligibility:

Men and women ages 14-80 who:

  • Live in Tieneguebougou, Bougoudiana, or surrounding villages in Mali
  • Are not pregnant
  • Have Sh infection
  • Have no other chronic medical conditions

Design:

  • Participants will be screened with:
  • Medical history
  • Physical exam
  • Blood and urine tests
  • Stool samples
  • Participants will be treated with a single dose of PZQ by mouth.
  • After receiving PZQ, participants will return to the clinic for blood and urine tests at the following times:
  • 4, 8, 24, 48, and 72 hours later
  • 5, 7, 9, and 14 days later
  • 1, 3, and 6 months later

Participants who are infected with Sh at the 6-month visit will get another treatment with PZQ.

...

Read the detailed description

Chronic filarial infection is associated with downregulation of immune responses to both helminth and non-helminth antigens. Praziquantel (PZQ) treatment of schistosomiasis is associated with a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia that is correlated with resistance to reinfection. We hypothesize that chronic filarial infection with Mansonella perstans (Mp) may attenuate post-treatment eosinophilia and thus impact resistance to reinfection. To address the first part of this question, we plan to compare post-PZQ reactions and reinfection rates in 20 subjects with schistosomiasis and Mp infection to those in 20 subjects with schistosomiasis and no evidence of filarial infection in an area coendemic for both infections in Mali. Signs and symptoms, complete blood counts, intracellular and serum cytokine levels, and markers of eosinophil activation will be assessed at baseline, 4 and 8 hours, and 1, 2, 3, 5, 7, 9, and 14 days post-treatment and compared between the two treatment groups. Schistosoma haematobium reinfection rates will also be compared at 1, 3, and 6 months post-treatment.

Conditions
Schistosomiasis
Being tested
Praziquantel
Keywords
Filariasis, Schistosoma Mansoni, Coinfection
Medical subject headings
Schistosomiasis, Filariasis, Coinfection

What participants receive

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

  • PraziquantelDrug

    Anthelminthic

Study groups in NCT02734186
Study groupRoleWhat they receive
ShExperimentalMono infected with Schistosoma haematobium
Receives: Drug: Praziquantel
ShMpExperimentalCoinfected with Schistosoma haematobium andMansonella perstans
Receives: Drug: Praziquantel

What is being measured

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

  1. Peak percentage change from baseline eosinophil count

    Measured: During the first 7 days post-treatment

Secondary outcomes (3)

  1. Peak absolute change from the baseline eosinophil count and peakpercentage change in eosinophil granule protein levels

    Measured: During the first 7 days post-treatment

  2. Frequency and severity of adverse events

    Measured: During the first 3 days post-treatment

  3. Number of subjects with detectable Sh eggs in urine

    Measured: At 1, 3 and 6 months post-treatment

Timeline

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

  1. First posted12 Apr 2016 (estimated)
  2. Study start6 Apr 2016
  3. Primary completion14 Dec 2018
  4. Study completion14 Dec 2018

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 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734186
Sponsor's protocol ID
999916084
Other IDs
16-I-N084
Status last verified
14 Dec 2018
First submitted
6 Apr 2016
Last updated
17 Dec 2019
Results posted
No

Publications

  • Dolo H, Coulibaly YI, Dembele B, Konate S, Coulibaly SY, Doumbia SS, Diallo AA, Soumaoro L, Coulibaly ME, Diakite SA, Guindo A, Fay MP, Metenou S, Nutman TB, Klion AD. Filariasis attenuates anemia and proinflammatory responses associated with clinical malaria: a matched prospective study in children and young adults. PLoS Negl Trop Dis. 2012;6(11):e1890. doi: 10.1371/journal.pntd.0001890. Epub 2012 Nov 1.

    PubMed 23133692

  • Fitzsimmons CM, Joseph S, Jones FM, Reimert CM, Hoffmann KF, Kazibwe F, Kimani G, Mwatha JK, Ouma JH, Tukahebwa EM, Kariuki HC, Vennervald BJ, Kabatereine NB, Dunne DW. Chemotherapy for schistosomiasis in Ugandan fishermen: treatment can cause a rapid increase in interleukin-5 levels in plasma but decreased levels of eosinophilia and worm-specific immunoglobulin E. Infect Immun. 2004 Jul;72(7):4023-30. doi: 10.1128/IAI.72.7.4023-4030.2004.

    PubMed 15213147

  • Keiser PB, Coulibaly YI, Keita F, Traore D, Diallo A, Diallo DA, Semnani RT, Doumbo OK, Traore SF, Klion AD, Nutman TB. Clinical characteristics of post-treatment reactions to ivermectin/albendazole for Wuchereria bancrofti in a region co-endemic for Mansonella perstans. Am J Trop Med Hyg. 2003 Sep;69(3):331-5.

    PubMed 14628953

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Praziquantel in people with Schistosomiasis, run by National Institute of Allergy and Infectious Diseases (NIAID).

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 7 inclusion and 16 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: withdrawn, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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?

Peak percentage change from baseline eosinophil count (time frame: During the first 7 days post-treatment). 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 NCT02734186, which also lists 3 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 17 Dec 2019.

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