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A SYNDEMIC BASED LINKAGE TO CARE INTERVENTION FOR HIGH RISK MEN WHO HAVE SEX WITH MEN

Primary objective: Does a personalised behaviour intervention comprising of targeted in depth screening on mental health problems and drug use increase help seeking behaviour among MSM who are at high risk for STIs and HIV. Secondary objectives:…

A randomized double-blind placebo-controlled phase 1 study regarding safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM 8101) in healthy male subjects.

To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.

The added effect of oral ondansetron to care-as-usual on persisting
vomiting in children aged 6 months to 6 years, presenting at primary care
out of hours service with acute gastro-enteritis and concomitant vomiting

The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…

Laser therapy for onychomycosis in patients with diabetes at risk for diabetic foot complications
A randomized, double blind controlled trial.

To determine the efficacy and safety of laser therapy in diabetes patients with risk factors for developing diabetic foot complications.

Comparison of effectiveness of hepatitis B revaccination schemes in healthy non-responders

To determine the efficacy of 3 different Hepatitis B vaccines (HBVAXPRO 40 micrograms, Fendrix and Twinrix) in Hepatitis B vaccine non-responders (ant-HBsAg < 10 IU/L) after one (standard) series of Hepatitis B vaccination with HBVAXPRO-10…

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients

MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…

Does continuous cefotaxime administration improve time to attainment and maintenance of target drug levels in intensive care patients?

The main objective is to assess target attainment of cefotaxime levels in the critically ill treated with either continuously or intermittently dosed cefotaxime. Secondary objectives are: to develop a predictive mathematical pharmacokinetic (PK)…

APA12/PANTER* study: ""PTM202 and modulation of host resistance to diarrheagenic Escherichia coli in a randomized placebo-controlled trial in healthy human subjects"

To study whether PTM202, a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg, improves the resistance of humans to traveller*s diarrhea as caused by diarrheagenic E. coli. PTM202 contains specific…

Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to surgical treatment of peri-implantitis; a single blind randomized controlled study

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plusmetronidazole therapy in conjunction with surgical treatment of peri-implantitis. The secondary objective is toassess the…

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

Quadrivalent HPV vaccination after effective treatment of Anal Intraepithelial Neoplasia in HIV+ men (VACCAIN-P)

The primary objective of the current study is to assess the efficacy of qHPV vaccination in preventing recurrence of high-grade AIN in HIV+ MSM with CD4 counts >350 x 10E6/l who were successfully treated for high-grade intra-anal AIN in the…

The role of the intestinal microbiome in enteric and systemic vaccine immune responses

Primary Objective: to investigate the role of the gut microbiota in RVV immune response Secondary Objectives: To investigate the role of the gut microbiota in tetanus and pneumococcal vaccine immune responses

Maternal pertussis (Tdap) vaccination and its effects on the immune response of the newborn up to 12 months of age.

Primary objective;Confirm superiority of IgG antibody levels against pertussis toxin (Ptx), present in the acellular vaccines, in infants at the age of 3 months of mothers having received a pertussis vaccine during pregnancy versus infants of…

A two-stage, controlled, open-label, dose-ascending first-in-man study to assess the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine

To evaluate the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine in healthy adults.

EARLY ORAL SWITCH THERAPY IN LOW-RISK
STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTION

The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…

A PHASE 2 RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF MHAA4549A,
A MONOCLONAL ANTIBODY, IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR
TREATMENT OF SEVERE INFLUENZA A INFECTION

2. OBJECTIVES2.1 SAFETY OBJECTIVESThe safety objectives for this study are as follows:* To evaluate the safety of MHAA4549A in combination with oseltamivir compared with placebo and oseltamivir in patients with severe influenza A, focusing on the…

A Phase II, global, randomized study to evaluate the efficacy and safety of Danirixin (GSK1325756) co-administered with a standard-of-care antiviral (oseltamivir), in the treatment of adults hospitalized with influenza (study 201023, DAHLIA)

Primary:To assess the efficacy of treatment with IV danirixin twice daily given with oral oseltamivir compared to oral oseltamivir twice daily on time to clinical response (TTCR)Secondary:Time to respiratory response (TTRR), clinical measures of…

Donor feces infusion for first episode of Clostridium difficile infection in patients at risk for recurrent infection

The primary objective of this study is to investigate whether FMT after antibiotic therapy is more effective than conventionalantibiotic therapy alone in patients with a first episode of CDI.

A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment

Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…

A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carriage of extended spectrum beta-lactamase or carbapenemase-producing Enterobacteriaceae in high-risk patients

The purpose of this study is to evaluate the efficacy of two antibiotics ( neomycin sulfate and colistin sulfate), followed by fecal bacteria therapy , to multidrug - resistant bacteria (E - ESBL and EPC) to be eradicated from the intestine.