Clinical Trials Logo
  1. Home
  2. Staphylococcus Aureus
  3. NCT00198289

Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs

Staphylococcus Aureus Clinical Trial

Official title:
A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs

Clinical Trial Summary

Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.

The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00198289
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 2
Start date April 2005
Completion date June 2006
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05073926 - Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Completed NCT01212120 - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections N/A
Completed NCT00801879 - Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection Phase 4
Terminated NCT03638947 - Reducing Perioperative S. Aureus Transmission N/A
Recruiting NCT05331885 - A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2 Phase 3
Recruiting NCT05094570 - Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP Phase 4
Not yet recruiting NCT05092464 - Exploratory Study to Evaluate the Application of NLAC Cream in Adults With Atopic Dermatitis N/A
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1
Enrolling by invitation NCT04666532 - S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues
Active, not recruiting NCT02572791 - Staph Household Intervention for Eradication (SHINE) Phase 4
Recruiting NCT04274348 - Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum N/A
Enrolling by invitation NCT05880069 - Clinical Outcomes in Patients With Infection by Resistant Microorganism
Completed NCT01011335 - Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial Phase 1/Phase 2
Completed NCT03816956 - Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 Phase 3
Not yet recruiting NCT04884958 - A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka
Completed NCT01105767 - Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees N/A
Completed NCT00475930 - Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates N/A
Completed NCT00507247 - Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus Phase 2
Recruiting NCT03220386 - Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making N/A
Completed NCT03140423 - Mupirocin-Iodophor ICU Decolonization Swap Out Trial Phase 4