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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.

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…

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…

The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia

Primary objective:­To determine whether endotoxin tolerance can be prevented by acetylsalicylic acid prophylaxis or can be reversed by acetylsalicylic acid treatment, expressed as an augmentation of pro-inflammatory cytokine levels during the second…

A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers

Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…

The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

The effect of Staphefekt on the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis.

To retrieve (in vivo) data about the effect of Staphefekt on the microbiome, including Staphylococcus aureus, and on disease severity in patients with atopic dermatitis.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

To evaluate the safety and tolerability of multiple escalating doses of intravenous WCK 4282 in healthy, adult, human subjects.To evaluate the pharmacokinetics (PK) of multiple escalating doses of 1g:1g (1 vial) of intravenous (IV) WCK 4282 every 8…

Hypertonic saline in primary ciliary dyskinesia: a pilot study

We hypothesize that hypertonic saline nebulizations improve respiratory symptoms and quality of life in PCD patients.

Phase 1, randomized, placebo controlled, double blind, single dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous IQNLF in healthy subjects.

To investigate the safety and tolerability of the intravenously applied (directly given into a blood vessel) new test compound.

Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.

Study objective: To evaluate the long-term (cost-)effectiveness of antibiotic treatment added to corticosteroids in the treatment of exacerbations of COPD.

The effects of oral dipyridamole treatment on the innate immune response during human endotoxemia.

Primary objective: The primary objective of the study is to determine the effect of oral dipyridamole treatment on the innate immune response induced by a lipopolysaccharide (LPS) challenge. Various pro- and anti-inflammatory cytokines will be…

Treatment of peri-implant mucositis; A randomized placebo controlled clinical study

The primary objective of this controlled clinical study is to evaluate the effect of chlorhexidine + CPC rinsing of the oral cavity for treatment of peri-implant mucositis.The secondary objectives are to assess the effectiveness of peri-implant…

The Qure study: Q-fever fatigue syndrome - response to treatment

To assess the efficacy of two treatment strategies for fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy (CBT).

Exploring prophylactic co-trimoxazole regimens at the removal of temporary catheters to prevent urinary tract infections: a randomised placebo controlled pilot study

To determine a suitable co-trimoxazole regimen for testing in a future larger clinical trial to determine the efficacy of antibiotic prophylaxis in patients with a temporary urinary tract catheter.

Relevance of Biomarkers and Clinical Predictors of Outcome in Unselected Population with Febrile Urinary Tract Infection at Primary Care and Emergency Department in a Prospective, Randomized Cohort Trial Comparing Short (7 days) Antibiotic Treatment with Conventional Treatment (14 days)

To assess clinical parameters and biomarkers in blood and urine in predicting bacteremia, need for hospital admission, clinical and bacteriologic cure and mortality in patients with fUTI.To determine whether a 7-day duration of antibiotic treatment…

A randomized, placebo-controlled, double blind volunteer study into the effect of milk ingredients on gastroenteritis caused by an attenuated E. coli.

We want to determine whether Lacprodan® PL-20 can effectively protect against enterotoxigenic E.coli induced travellers* diarrhea in humans. In the present double-blind, placebo-controlled, randomized parallel study, the effect of oral milk protein…

A randomized, placebo-controlled, double blind human trial into the effect of Protecflor on gastroenteritis caused by attenuated E. Coli

We want to study whether consumption of Protecflor can improve the resistance of humans to intestinal ETEC infection. An important parameter of intestinal resistance is the so-called colonization resistance. The colonization resistance is inversely…

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

The purpose of the study is to investigate to what extent WCK 4282 is safe and tolerated. It will also be investigated how quickly and to what extent WCK 4282 is absorbed and eliminated from the body (this is called pharmacokinetics).

A randomized, double-blind, placebo-controlled study of ascending single low doses of LPS administered intravenously to healthy volunteers to assess the dose-response relation.

To assess the relationship between administration of low doses of LPS (0.5, 1 and 2 ng/kg bodyweight) and the inflammatory response (cytokine levels and hs-CRP) in healthy male volunteers;To assess the duration of tolerance/paralysis of the immune…