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NCT ID: NCT00261807 Completed - Fournier's Gangrene Clinical Trials

Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections

Start date: June 2005
Phase: N/A
Study type: Interventional

Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.

NCT ID: NCT00218686 Withdrawn - HIV Infections Clinical Trials

A Network Intervention for Prevention of HIV Infection in Chennai, India - 1

Start date: January 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners in Chennai India.

NCT ID: NCT00183287 Completed - HIV Infections Clinical Trials

Long Term Follow-Up of HIV Infected Patients Who Have Previously Participated in HIV Clinical Trials

Start date: n/a
Phase:
Study type: Observational

The purpose of this study is to monitor the progression of HIV infection and HIV-related disease processes in patients who have previously participated in HIV clinical trials.

NCT ID: NCT00183261 Completed - HIV Infections Clinical Trials

Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection

Start date: March 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the HIV vaccine MRKAd5 HIV-1 gag/pol/nef followed by treatment interruption can increase immune system function in adults with acute or recent HIV infection who have started taking anti-HIV drugs.

NCT ID: NCT00148278 Completed - Septic Shock Clinical Trials

Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock

CATS
Start date: October 1999
Phase: Phase 2/Phase 3
Study type: Interventional

Catecholamines infusion is a major component of septic shock management. International guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III trials are lacking. The present study aimed at comparing the efficacy and safety of norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.

NCT ID: NCT00145795 Completed - HIV Infections Clinical Trials

A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment

Start date: April 2004
Phase: Phase 4
Study type: Interventional

Our goal is to determine if a change in therapy to one containing Kaletra can improve the immune response in patients who have previously been immune partial responders or non-responders. We also are interested in knowing if this agent improves immune response by affecting cluster of differentiation 4 (CD4) + T cell death (apoptosis) or by further inhibiting (preventing) ongoing, low-level, viral replication to levels below detection by current viral load measurements. This will help us understand why immune responses to effective antiretroviral therapy are so different and help determine some possible guidelines for managing patients with poor immune responses. Hypothesis: Patients with poor immune responses to HAART who receive Kaletra in place of their current PI or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) while continuing their current 2 NRTI backbone will have improved immune response to therapy compared to patients who continue their current regimen.

NCT ID: NCT00130221 Completed - Sepsis Clinical Trials

Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections

Start date: June 2005
Phase: Phase 1
Study type: Interventional

Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.

NCT ID: NCT00125099 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also test whether the vaccine can increase the immune system function in these participants.

NCT ID: NCT00110812 Completed - HIV Infections Clinical Trials

Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People

STALWART
Start date: September 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.

NCT ID: NCT00106171 Completed - HIV Infections Clinical Trials

Anti-HIV Medications for People Recently Infected With HIV

Start date: May 2005
Phase: Phase 4
Study type: Interventional

It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV. Study hypothesis: A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection.