View clinical trials related to Infection.
Filter by:Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside.However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport. Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis. This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting.
Cancer of the anus occurs at very high rates in young men with HIV and is caused by a virus called human papillomavirus (HPV). Anal cancer has increased during the HIV epidemic despite effective therapies for HIV. Unfortunately, anal cancer presents at a late stage because there is no screening program to find it at an early stage. Rates of other cancers such as cervical cancer have been reduced through the use of Pap smears. The researchers' plan is to do the same type of screening for anal cancer as has been done for cervical cancer. If abnormalities are found then treatment can be started. The researchers hope that this approach will help to prevent anal cancer. Testing for HPV will also be done to see if this helps to detect early cancer and to see how accurate different tests, pathologists and clinical examiners are at detecting and agreeing on any abnormalities. The main outcome is the presence of any pre-cancerous or early cancer changes as determined by high resolution anoscopy (HRA). HRA involves looking through a microscope into the anus and this allows very tiny changes to be identified. Pieces of tissue can then be taken to make a definite diagnosis.
This study is to determine whether antibiotic therapy is needed for patients with non-life threatening soft tissue infections. Most patients with these soft tissue infections are presently treated with antibiotics. Many of these infections resolve without proper antibiotic treatment. Treatment of patients with antibiotics after surgical drainage of an abscess may not be necessary and indiscriminate use of antibiotics may lead to colonization by drug-resistant organisms. Subsequent infection by drug resistant organisms may limit the choice of antibiotics in more complicated infections. A comparison between antibiotic treatment and no antibiotic treatment in surgically treated, uncomplicated soft tissue infections is needed to address this very important question.
This double blinded RCT will help to ascertain the usefulness of prophylactic antibiotics in the management of uncomplicated dog bites, utilizing currently best available antibiotics (Augmentin) and an important clinical outcome of infection. By enrolling 100-150 patients in this pilot trial as part of a k-award the investigators plan to utilize the point estimates of infection, side effects and other important outcomes and incorporate these into a cost most to determine the most cost effective management of these wounds and to determine if further study is warranted based on the findings.
Patients who have been treated for hepatitis C virus (HCV) infection who have failed to respond to anti-viral treatment are often concerned about their ongoing liver disease and are therefore looking for alternative treatments which might prevent fibrosis progression. This view is endorsed by patient representative groups (including Charles Gore at the HepC Trust) who have welcomed this trial protocol. The study is a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2. Phase 1 (observation phase, 0 to 8 weeks) and Phase 2 (treatment phase with warfarin anticoagulation, 8 to 16 weeks). Study completed at end of Phase 2.
The purpose of this study is to optimize the management of patients treated for invasive fungal infections by establishing a real-time, continuous clinical data base that will capture and monitor trends in the epidemiology, diagnosis, treatment and outcomes of invasive fungal infections; reflect routine clinical management of patients with invasive fungal infections in order to evaluate treatment and provide a rationale for future treatment paradigms; and allow physicians to assess adherence to institutional clinical practice guidelines, validate current standardized definitions for patients with invasive fungal infections and promote change where appropriate.
Fungal infections are leading causes of morbidity and mortality in transplant recipients, yet comprehensive epidemiologic studies in this area are lacking. For this reason, the Centers for Disease Control and Prevention have provided a grant to the University of Pittsburgh to study this subject. The study has four specific aims: 1. To determine the risk of fungal infections in a center where "tolerogenic" immunosuppressive protocols are currently in place, and to determine whether there are any measures of immune system function which correlate with risk of fungal infection. 2: To create a repository of serum, urine and bronchoalveolar lavage specimens for the purpose of determining the effectiveness of novel diagnostic tests for invasive fungal infections. Such a repository could also be utilized for the purpose of determining the effectiveness of novel diagnostic tests for viral infections such as West Nile Virus, cytomegalovirus, HHV-6 and HHV-8. Specific aim 1 will be investigated by creating a prospective database of solid organ transplant recipients at the University of Pittsburgh Medical Center, including demographic factors as well as subsequent development of infection. The immune function of patients will be assessed by measuring T cell subsets and assessing T cell function using the Cylex assay. Specific aim 2 involves collection of serum, urine and bronchoalveolar lavage fluid. These specimens will be stored and later tested at the Centers for Disease Control and Prevention in the assessment of novel tests developed for the diagnosis of invasive fungal infections.
Therapeutic options for serious fungal infections are limited by intrinsic and acquired resistance to existing antifungal agents. For example, zygomycetes (such as Mucor spp.) are intrinsically resistant to voriconazole and caspofungin. Yet, the only available therapeutic option, amphotericin, is associated with significant renal toxicity, even in lipid formulations. Posaconazole is a new antifungal drug, not yet Food and Drug Administration (FDA) approved, but which has excellent in vitro activity against some intrinsically resistant fungi such as the zygomycetes. The intent of this trial is to provide access to posaconazole to patients with serious fungal infections which are refractory to standard antifungal therapies or invasive fungal infections for which there are currently no effective therapies. Secondly, the drug will also be made available to patients with invasive fungal infections who: - have experienced serious or severe toxicities while receiving standard antifungal therapies; - have pre-existing renal dysfunction which precludes use of standard antifungal therapies; or - are chronically immunosuppressed with a history of invasive fungal infections previously treated with posaconazole in other clinical trials, and who require oral antifungal suppressive therapy as maintenance treatment to prevent recurrence. This is a multicenter, open-label, non-comparative experimental treatment use protocol. The experimental treatment use protocol will provide the investigational medication posaconazole where no other drug is commercially available. Posaconazole is given as an orally or enterally administered suspension. The duration of therapy is at the discretion of the investigator. Safety assessments will include an electrocardiogram [ECG] (to ensure no QTc interval prolongation) performed at baseline and serum/urine pregnancy testing performed at baseline and every three months after initiation of therapy. Plasma concentrations will be obtained if there is evidence of clinical failure. No other tests will be performed specifically for the experimental treatment use protocol.
Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics considers the interaction of the drug at the site of infection over time. Mathematical models of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are sufficient to treat infection with organisms of different minimal inhibitory concentrations of the antibiotic. Based on these models, there has been speculation that the antibiotic cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the "susceptible" range. This study of patients treated with cefepime will involve the collection of blood to determine cefepime concentrations, and determine if those concentrations are effective in killing the bacteria at the site of infection.