A Bioequivalence Study of SKF101804 Cefixime Versus Cefixime Reference Formulation in Healthy Adults...
InfectionsBacterialCefixime is an orally active third generation cephalosporin indicated for the treatment of acute exacerbations of chronic bronchitis, acute otitis media, uncomplicated acute cystitis and uncomplicated pyelonephritis. Cefixime acts by inhibiting the action of proteins involved in the synthesis of bacterial cell walls, which leads to bacterial cell lysis and cell death. Due to lack of bioequivalence between tablet/capsule and suspension formulation of cefixime, consideration needs to be given if the oral suspension is to be substituted for the tablet/capsule. This study is designed to assess whether test SKF101804 cefixime 400 milligrams (mg) capsule is bioequivalent to reference cefixime 400 mg capsule under fasting conditions in healthy adults. Subjects will be randomized in crossover manner to receive single oral doses of treatment A (SKF101804 cefixime test capsules) and treatment B (reference cefixime capsules), followed by a washout period of 7-14 days. Approximately 26 subjects will be included in the study and total duration in the study for each subject will be approximately 5 to 7 weeks.
Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL) Trial
Bacterial InfectionsA trial to assess cumulative incidence of skin and soft tissue infections (SSTI) in infants (by three months of age) born to mothers receiving a single-dose of 2 grams of oral azithromycin during labour (or immediately prior to delivery in the case of caesarean section), compared to infants whose mothers received placebo.
The Study on Bacterial Load Following Open-to-air Management in Burn Patients.
BurnsInfection Wound1 moreBurns are one of the common forms of trauma and are a cause of unintentional death and injury. Management of burns becomes complex due to multiple associated complications, for instance, secondary infection of burn wounds is the most common complication associated with burn injuries. Treatment of bacterial infections with antibiotics is becoming more challenging due to the development of multidrug-resistance. Hence, there is a critical need to investigate and establish non-antibiotic approaches to prevent colonization, control growth, and eliminate bacteria from burn wounds. Recent studies have explored the beneficial effects of open-to-air strategies on wound healing. Based on the evidence, the investigators hypothesize that bacterial load in burn wounds will be lowered when treated with an open-to-air strategy compared to the traditional closed wound approach.
A Single Center Four Part Study in Healthy Adult Subjects to Evaluate: the Safety, Tolerability...
InfectionsBacterialGSK945237 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK945237 has demonstrated in vitro and in vivo activity against Gram positive [including methicillin resistant Staphylococcus aureus (MRSA)] and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials. This study will be conducted in four (4) parts, with a single oral dose being explored in Part A (2400 mg) and repeat oral doses (b.i.d. and q.d.) being explored in Part B. Parts C and D will be optional evaluations of repeat oral doses of linezolid and a comparative evaluation of the effect of GSK945237 and moxifloxacin, respectively. Parts A and B will be single-blind, randomized, placebo-controlled, dose-rising (Part B only) studies of healthy subjects to evaluate the safety, tolerability and pharmacokinetics of GSK945237. The proposed doses range from 400 mg to 2400 mg. Part C will be a single-blind, randomized, and placebo-controlled repeat dose evaluation of 600 mg (b.i.d.) of linezolid. Part D will be a single-blind, randomized, placebo-controlled, two period crossover study. The proposed doses for Part D will be 1200 mg GSK945237 and 400 mg moxifloxacin.
A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months...
Bacterial Infections; Virus DiseasesThe purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3 formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.
Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™...
Bacterial InfectionsVirus DiseasesThis is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12...
Bacterial InfectionsVirus DiseasesThis study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women...
Streptococcal InfectionGram-positive Bacterial Infection1 moreThe study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
Reducing Vaginal Infections in Women
Bacterial DiseasesOther Mycoses1 moreThe purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douching, bathing, and sexual practices can influence the risk of vaginal infections. Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16 and older, living in Mombasa. Study procedures will include sexual behavior questions, physical examinations including pelvic exams, testing of vaginal and cervical secretions for STDs, urine collection and blood samples. Participants will receive 2 different types of pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no medication). Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals.
Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections
Carbapenem-Resistant Enterobacteriaceae InfectionKPC2 moreThis is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae infections at a tertiary care hospital. The objectives of the study are to demonstrate successful treatment of KPC containing Enterobacteriaceae infections with IMI/REL including in bacteremia, and to analyze treatment outcomes in use of IMI/REL for KPC-producing infections compared to historical clinical outcome data with CZA and MVB use at the same institution.