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NCT ID: NCT00299663 Completed - Clinical trials for Streptococcal Infections

Long Term Follow-up of Patients With Group A Streptococcal Infection Originating From the Genital Tract

Start date: February 2006
Phase: N/A
Study type: Observational

Group A streptococcus (GAS) causes a variety of human infections. It is also an uncommon but serious cause of postpartum infections. In contrast to group B streptococcus (GBS) infection, which causes illness and death in newborns disproportionately more often than it does in mothers, perinatal GAS infection primarily affects mothers . Invasive GAS infection is defined by the isolation of GAS from a normally sterile site (e.g., blood) or by the isolation of GAS from a nonsterile site in the presence of the streptococcal toxic shock syndrome or necrotizing fasciitis. A postpartum case of invasive GAS is defined as isolation of GAS during the postpartum period, in association with a clinical postpartum infection (e.g., endometritis) or from either a sterile site or a wound infection. Because of the burden and severity of invasive GAS infection, the Centers for Disease Control and Prevention (CDC) hosted a meeting in to formulate guidelines for responding to postpartum and postsurgical GAS infections. However, we could not find any recommendations for long-term follow-up of patients who had GAS infection subsequent to delivery or gynaecological procedures, or further recommendations regarding subsequent delivery or gynaecological invasive procedures. It is possible that women who had GAS as a cause of vaginal infection may have a tendency to be carriers of this organism, but this has never been proven. We believe it is of importance to determine if women who have had one infection may be long-term carriers which may pose a risk during future pregnancies. The objective of the present study is to evaluate the incidence of long term gynaecological carrier state of patients who had GAS invasive infection following delivery, and to provide guidelines for follow-up and treatment of such patients. The proposed study may answer the question whether this endogenous GAS origin represents chronic GAS carrier state, similar to the known GBS carrier state. As some of these patients had severe infections (sometimes life threatening) a protocol for long-term follow up and management is necessary in case an invasive procedure is done (IUD insertion, endometrial biopsy, curettage or delivery) in order to prevent recurrent infection. The information collected in the study will enable us to afford recommendations for follow up and prophylaxis in the future.

NCT ID: NCT00299520 Completed - Clinical trials for Complicated Skin and Skin Structure Infection

Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)

Start date: June 2005
Phase: Phase 3
Study type: Interventional

This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).

NCT ID: NCT00298077 Completed - Infection Clinical Trials

A Retrospective Review of Infections Usually Observed in Transplant Recipients

Start date: August 2006
Phase:
Study type: Observational

The study will identify patients with infections commonly observed in transplant recipients, describe the epidemiology of their infection, study the risk factors associated with various infections and examine strategies of early diagnosis and prevention of infection

NCT ID: NCT00296829 Completed - Influenza Clinical Trials

Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly

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

All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). Primary Objective: To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine. Secondary Objectives: - To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain. - To describe the safety profile after the vaccination in each study group - To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency. Observational Objectives: - To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site. - To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group. - To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity. - To evaluate the cellular mediated immune response in a subset of subjects.

NCT ID: NCT00296660 Completed - HIV Infections Clinical Trials

Acute HIV Infection Observational Study

Start date: June 2006
Phase: N/A
Study type: Observational

The purpose of this study is to collect data and body fluid samples from people with acute or established HIV infection and from HIV uninfected people. Data from this study will be used to better understand properties of HIV, including HIV transmission and the differences between acute and established HIV infections.

NCT ID: NCT00294047 Completed - Clinical trials for Infections, Papillomavirus

Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

Start date: February 16, 2006
Phase: Phase 3
Study type: Interventional

This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.

NCT ID: NCT00290290 Completed - Clinical trials for Postoperative Wound Infection

Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Start date: September 2003
Phase: Phase 3
Study type: Interventional

Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.

NCT ID: NCT00289991 Completed - Clinical trials for Antifungal Prophylaxis of Invasive Fungal Infections

Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

IMPROVIT
Start date: March 2006
Phase: Phase 3
Study type: Interventional

Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.

NCT ID: NCT00289588 Completed - Cellulitis Clinical Trials

An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers

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

The main purpose of this study is to determine if applying mupirocin into soldiers noses who are colonized with methicillin-resistant Staphylococcus aureus (MRSA) will reduce infections in them and their cohort of fellow soldiers.

NCT ID: NCT00288197 Completed - Clinical trials for Invasive Fungal Infections

A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections

Start date: January 2006
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.