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Trial record 30 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

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

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ClinicalTrials.gov Identifier: NCT02734186
Recruitment Status : Withdrawn
First Posted : April 12, 2016
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date  ICMJE April 6, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date November 25, 2019
Study Start Date  ICMJE April 6, 2016
Actual Primary Completion Date December 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
Peak percentage change from baseline eosinophil count [ Time Frame: During the first 7 days post-treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02734186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Peak absolute change from the baseline eosinophil count and peakpercentage change in eosinophil granule protein levels [ Time Frame: During the first 7 days post-treatment ]
  • Frequency and severity of adverse events [ Time Frame: During the first 3 days post-treatment ]
  • Number of subjects with detectable Sh eggs in urine [ Time Frame: At 1, 3 and 6 months post-treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in People With Schistosomiasis
Official Title  ICMJE Effect of Concomitant Mansonella Perstans Microfilaremia on Immune Responses Following Single Dose Praziquantel in Subjects With Schistosomiasis: A Pilot Study
Brief 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. 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.

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Schistosomiasis
Intervention  ICMJE Drug: Praziquantel
Anthelminthic
Study Arms  ICMJE
  • Experimental: Sh
    Mono infected with Schistosoma haematobium
    Intervention: Drug: Praziquantel
  • Experimental: ShMp
    Coinfected with Schistosoma haematobium andMansonella perstans
    Intervention: Drug: Praziquantel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 15, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
800
Actual Study Completion Date  ICMJE December 14, 2018
Actual Primary Completion Date December 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA (SCREENING):

    1. Male or non-pregnant female subjects
    2. Age 14-80 years (per participant self-report)
    3. 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.

EXCLUSION CRITERIA (SCREENING):

  1. Known to be pregnant (by history)
  2. 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
  3. History of hypersensitivity reaction to PZQ.
  4. Weight less than 20 kg

INCLUSION CRITERIA (INTERVENTIONAL STUDY):

  1. S. haematobium infection documented at screening and within 14 days prior to the baseline visit
  2. The subject agrees to storage of samples for study.

EXCLUSION CRITERIA (INTERVENTIONAL STUDY):

  1. Pregnancy (by urine beta-HCG)
  2. Chronic kidney or liver disease
  3. Hgb <10 mg/dL
  4. PZQ treatment since the screening visit
  5. Concomitant Schistosoma mansoni, Wuchereria bancrofti (Wb) or Onchocerca volvulus infection
  6. Use of immunosuppressive therapies, including steroids, within the past month
  7. Any condition that in the investigator s opinion places the subject at undue risk by participating in the study.

EXCLUSION OF CHILDREN AND PREGNANT WOMEN:

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Mali
 
Administrative Information
NCT Number  ICMJE NCT02734186
Other Study ID Numbers  ICMJE 999916084
16-I-N084
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy D Klion, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 14, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP