Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02963129
Other study ID # 2666
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received August 9, 2016
Last updated November 9, 2016
Start date June 2017
Est. completion date December 2017

Study information

Verified date November 2016
Source Hospital Italiano de Buenos Aires
Contact Marcelo MS Serra, MD
Phone 49590200
Email marcelo.serra@hospitalitalino.org.ar
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial 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.


Description:

Hereditary hemorrhagic telangiectasia is a vascular dysplasia characterized by the development of mucocutaneous telangiectasia and arteriovenous malformations in organs such as brain, lung, liver and tube digestivo. Is considered a rare disease, although It means that there is a substantial underdiagnosis. The overall prevalence is 1/5000.

Approximately 60% of the general population hosts strains of Staphylococcus aureus (S. aureus) intermittently and are called intermittent carriers, 20% represent persistent carriers harboring the same strain of S. aureus and 20% of the population are never carriers.

On this concept, one might think that HHT patients in whom there is an active and pathological vascular remodeling that causes bleeding, and inflammation is a known activator of abnormal angiogenesis; reducing an inflammatory factor as microbial through the eradication of nasal S. aureus could be useful to reduce bleeding in this population, directly impacting on quality of life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over 18 years with possible or confirmed HHT as diagnostic criteria CuraƧao.

- Patients with nasal S. aureus colonization culture positive

Exclusion Criteria:

- Refusal to participate in the study or the informed consent process.

- Hypersensitivity or contraindication for topical mupirocin.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Mupirocin
Mupirocin ointment in the nose for 5 days
Other:
Placebo
Placebo ointment in the nose for 5 days

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires, Gascon 450 Buenos Aires
Argentina Hospital Italiano de Buenos Aires, Peron 4190 Ciudad Autonoma de Buenos Aires Capital Federal

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nosebleed by sadick scale 60 days No
Secondary Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive 60 days No
See also
  Status Clinical Trial Phase
Completed NCT05334017 - Xylometazoline and Cocaine for Nasal Vasoconstriction Phase 4
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Recruiting NCT01886768 - Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy N/A
Recruiting NCT00390663 - A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children Phase 4
Suspended NCT04054687 - Intranasal TXA for Anterior Epistaxis in the Emergency Department Phase 2
Completed NCT02285634 - The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial. N/A
Completed NCT01485224 - Efficacy of Thalidomide in the Treatment of Hereditary Hemorrhagic Telangiectasia Phase 2
Completed NCT00793117 - The Effect of Packing in Post Operative Management of FESS Phase 4
Recruiting NCT06259292 - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Recruiting NCT03850964 - Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz) Phase 2/Phase 3
Recruiting NCT05281952 - Medico-economic Evaluation of Management Strategies for Severe Epistaxis N/A
Completed NCT03360045 - Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis Phase 4
Completed NCT04279288 - The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures N/A
Completed NCT03912051 - Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting N/A
Not yet recruiting NCT02677467 - Correlation Between Epistaxis and Cardiovascular Disease N/A
Completed NCT01314274 - Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Phase 2
Terminated NCT01051427 - Control of Epistaxis With Surgiflo N/A
Completed NCT00863356 - Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis N/A
Recruiting NCT05269849 - Sirolimus for Nosebleeds in HHT Phase 2
Not yet recruiting NCT05343650 - NOVAPAK Nasal Packing in Shellfish Allergic Patients Phase 4