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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 wit

    Detailed Summary: 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.
    Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

    Current Primary Outcome: Peak percentage change from baseline eosinophil count [ Time Frame: During the first 7 days post-treatment ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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: Same as current

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: April 6, 2016
    Date Started: March 14, 2016
    Date Completion: September 30, 2017
    Last Updated: May 12, 2017
    Last Verified: February 24, 2017