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

NCT02734186 | Withdrawn Phase 4

• 2 other identifiers: 99991608416-I-N084
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. ...

Conditions

Schistosomiasis

Keywords

Filariasis; Schistosoma Mansoni; Coinfection

Outcome Measures

Primary Outcomes (1)

• Peak percentage change from baseline eosinophil count

  During the first 7 days post-treatment

Secondary Outcomes (3)

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

  During the first 7 days post-treatment

• Frequency and severity of adverse events

  During the first 3 days post-treatment

• Number of subjects with detectable Sh eggs in urine

  At 1, 3 and 6 months post-treatment

Study Arms (2)

Sh

EXPERIMENTAL

Mono infected with Schistosoma haematobium

Drug: Praziquantel

ShMp

EXPERIMENTAL

Coinfected with Schistosoma haematobium andMansonella perstans

Drug: Praziquantel

Interventions

Praziquantel DRUG

Anthelminthic

Sh; ShMp

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female subjects
• Age 14-80 years (per participant self-report)
• Resident of Tienegubougou, Bougoudiana or surrounding villages
• \. Consent to a blood draw to screen for filarial infection and a urine exam to screen for schistosomiasis
• \. Must be willing to have blood samples stored.

You may not qualify if:

• 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
• S. haematobium infection documented at screening and within 14 days prior to the baseline visit
• The subject agrees to storage of samples for study.
• Pregnancy (by urine beta-HCG)
• Chronic kidney or liver disease
• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Related Publications (3)

• 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.

  PMID: 23133692 BACKGROUND

• 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.

  PMID: 15213147 BACKGROUND

• 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.

  PMID: 14628953 BACKGROUND

MeSH Terms

Conditions

Schistosomiasis; Filariasis; Coinfection

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases; Spirurida Infections; Secernentea Infections; Nematode Infections

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amy D Klion, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: April 6, 2016
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: December 17, 2019

Record last verified: 2018-12-14