Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00737269
Other study ID # CR015043
Secondary ID CEFTOSSK4001
Status Completed
Phase Phase 4
First received August 14, 2008
Last updated March 1, 2013
Start date June 2008
Est. completion date January 2010

Study information

Verified date March 2013
Source Ortho-McNeil Janssen Scientific Affairs, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic therapy.


Description:

A prospective, multi-center, observational study involving 1200 patients hospitalized for the treatment of cSSTIs. The study will be conducted at approximately 50 hospitals in the US. Patients who consent to participate in the registry will be enrolled in the registry within 24 hours of initial IV antibiotic therapy for treatment of one or more cSSTI types. Sites will treat patients according to their usual clinical practice. The objective of this registry is to characterize cSSTIs with respect to patient characteristics and describe patient outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 1081
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with a diagnosis of complicated skin and soft-tissue infection

- Patients who require IV antibiotic therapy as a primary treatment regimen

- Patients who are deemed to be cognitive and able to provide written informed consent and follow-up information.

Exclusion Criteria:

- Patients with a diagnosis at the index infection site of necrotizing soft tissue infection, burn, gangrene, decubitus ulcer, animal or human bites, known or suspected osteomyelitis, or mediastinitis

- Patients for whom amputation or a complete resection of the infection site is a planned component of treatment

- Patients who are pregnant

- Patients simultaneously participating in any interventional clinical trial

- Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements

- Patients who are employees of the investigator or study hospital

Study Design

Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ortho-McNeil Janssen Scientific Affairs, LLC
See also
  Status Clinical Trial Phase
Completed NCT05529173 - Povidone-Iodine for Nasal Decolonization Phase 4
Recruiting NCT03295955 - Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy N/A
Not yet recruiting NCT05276687 - Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection Phase 4
Completed NCT02776774 - Topical Antibiotic Treatment for Spine Surgical Site Infection
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Completed NCT03148067 - Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT01890720 - Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section N/A
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2
Completed NCT02919410 - Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial N/A
Completed NCT02020018 - Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection N/A
Completed NCT01741649 - Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section N/A
Not yet recruiting NCT01457859 - Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery Phase 4
Completed NCT01340534 - Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection Phase 3
Completed NCT03365219 - Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections N/A
Completed NCT01026259 - Local Warming of Surgical Incisions Phase 3
Completed NCT03574090 - Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery Phase 4
Completed NCT03199911 - Topical Antibiotic Prophylaxis for Eyelids Phase 4