Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

NCT02963129 | Unknown Phase 3 DMC

• 1 other identifier: 2666
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Compare the frequency of epistaxis and quality of life related to nasal bleeding in patients with HHT colonized with sataphylococo before and after being treated with mupirocin ointment.

Conditions

Hereditary Hemorrhagic Telangiectasia; Epistaxis

Keywords

Hereditary Hemorrhagic Telangiectasia; Epistaxis

Outcome Measures

Primary Outcomes (1)

• Nosebleed by sadick scale

  60 days

Secondary Outcomes (1)

• Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive

  60 days

Study Arms (2)

Mupirocina

EXPERIMENTAL

topical mupirocin nasal ointment and nasal solid petroleum jelly for 5 consecutive days and then just nasal solid petroleum jelly to complete the 60 total days

Drug: Mupirocin

Control

PLACEBO COMPARATOR

topical placebo nasal ointment and nasal solid petroleum jelly for 5 consecutive days and then just nasal solid petroleum jelly to complete the 60 total days

Other: Placebo

Interventions

Mupirocin DRUG

Mupirocin ointment in the nose for 5 days

Also known as: Mupirocina 2% ointment

Mupirocina

Placebo OTHER

Placebo ointment in the nose for 5 days

Also known as: ointment

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years with possible or confirmed HHT as diagnostic criteria Curaçao.
• Patients with nasal S. aureus colonization culture positive

You may not qualify if:

• Refusal to participate in the study or the informed consent process.
• Hypersensitivity or contraindication for topical mupirocin.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (2)

Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

Location

Hospital Italiano de Buenos Aires, Gascon 450

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Epistaxis

Interventions

Mupirocin; Ointments

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Marcelo MS Serra, MD

  Staff of the Department of Clinical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo MS Serra, MD

CONTACT

49590200; marcelo.serra@hospitalitalino.org.ar

Cristina CE Elizondo, MD

CONTACT

49590200; cristina.elizondo@hospitalitalino.org.ar

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: November 15, 2016
• Study Start: June 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2)