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NCT ID: NCT00429325 Completed - Acute Diarrhea Clinical Trials

Fecal Calprotectin: Cheap Marker for Diagnosing Acute Infectious Diarrhea

Start date: January 2004
Phase: N/A
Study type: Observational

Every year more than 4 billion cases of diarrhea occur worldwide culminating in about 2.5 million deaths, almost all in the developing nations. Reliable diagnosis of patients with acute infectious diarrhea which could be appropriately managed with antibiotics at presentation still remains a formidable challenge to the clinicians. To address this issue of predicting microbiological infectious etiology for diagnosing acute infectious diarrhea, we would evaluate stools from all patients with acute diarrhea with culture, Guaiac based fecal occult blood test (FOBT), Calprotectin and lactoferrin assays simultaneously. This would be the first study evaluating fecal calprotectin as a diagnostic marker in acute diarrhea

NCT ID: NCT00428818 Completed - Infection Clinical Trials

Trimethoprim-Sulfamethoxazole or Doxycycline for Skin and Soft Tissue Infections

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

Background: In many communities, skin and soft tissue infections (SSTI) with MRSA have become more prevalent than infections with β-lactam susceptible bacteria. This has necessitated altered empiric antimicrobial therapy of SSTI to cover MRSA. Objective: To evaluate empiric therapy with trimethoprim-sulfamethoxazole or doxycycline for outpatient SSTI in an area of high MRSA prevalence. Design: Randomized, prospective, open-label investigation. Setting: Emergency Department of Parkland Hospital in Dallas, Texas. Patients: Adults with SSTI. Intervention: Empiric oral therapy with trimethoprim-sulfamethoxazole (160 mg/800 mg, twice daily) or doxycycline (100 mg, twice daily). Measurement: The primary endpoint was clinical failure defined as hospitalization or change in antibiotic therapy over the 10 to 14 days after initial emergency department evaluation.

NCT ID: NCT00427141 Completed - Clinical trials for Infections, Bacterial

A Three-Part Study Of GSK580416 In Healthy Subjects

Start date: October 2006
Phase: Phase 1
Study type: Interventional

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.

NCT ID: NCT00427076 Completed - Sepsis Clinical Trials

Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections

Start date: June 2007
Phase: Phase 3
Study type: Interventional

Methicillin-resistant Staphylococcus aureus (SA) is a major pathogen causing mainly health-care associated infections and, lately, also community acquired infections. Few treatment choices exist to treat these infections. The currently recommended antibiotics for these infections are glycopeptides (vancomycin or teicoplanin). Glycopeptide treatment hs several disadvantages. It is a last resort antibiotic family that should be reserved for the future; Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to both agents; treatment can only be given intravenously; and use of vancomycin has led to the development of SA strains with partial or complete resistance to vancomycin. Cotrimoxazole is an old antibiotic active against most strains of MRSA, depending on local epidemiology. Study hypothesis: The purpose of this study is to show that cotrimoxazole is as effective as treatment with vancomycin for invasive MRSA infections. We plan a randomized controlled trial comparing treatment with cotrimoxazole vs. vancomycin for invasive MRSA infections. The primary efficacy outcome we will assess will be Improvement or cure with or without antibiotic modifications, defined as: survival at 7 days post randomization with resolution of fever (<38 for two consecutive days) and resolution of hypotension (>90 systolic without need for vasopressor support); and physician's assessment that the primary infection was improved or cured. The primary safety outcome will be all-cause 30-day survival.

NCT ID: NCT00426933 Completed - Clinical trials for Soft Tissue Infections

Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

Start date: January 2007
Phase: Phase 2
Study type: Interventional

multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.

NCT ID: NCT00424190 Completed - Clinical trials for Bacterial Infections

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

cSSSI
Start date: February 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

NCT ID: NCT00423657 Completed - Clinical trials for Bacterial Infections

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

NCT ID: NCT00423046 Completed - Clinical trials for Infections, Papillomavirus

Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age

Start date: January 24, 2007
Phase: Phase 3
Study type: Interventional

HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in > 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® [quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV vaccine and Gardasil® have different compositions and are expected to have different efficacy profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted. This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18) to Gardasil® in healthy adult females 18-45 years of age. The Protocol Posting has been updated as the study will be extended by 3 additional years.

NCT ID: NCT00420966 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

Start date: October 2005
Phase:
Study type: Observational

The purpose of this study is to determine the utilization patterns and compliance rates of palivizumab, which is a monoclonal antibody therapy used to prevent respiratory syncytial virus infection.

NCT ID: NCT00419991 Completed - Clinical trials for Staphylococcal Infections

Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection

Start date: January 2007
Phase: Phase 4
Study type: Interventional

Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms and provides activity against emerging multi-drug resistant pathogens. The purpose of this protocol is to determine the linkage between time related clinical measures of infection response and time to bacterial eradication in patients with intravascular catheter infections caused by Staphylococcus epidermidis and other coagulase negative staphylococci.