Neoplasms

Digestive System Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Communicable Diseases

Bacterial Infections

Gastritis

Disease Attributes

Gastrointestinal Diseases

Stomach Diseases

Mycoses

Bacterial Infections and Mycoses

Gastroenteritis

Stomach Cancer

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Markus Gerhard, Prof.

Christian Schulz, MD

The clinical management of H. pylori infection depends essentially on two factors, prevalence and local resistance. In Germany, only limited data from rather small cohorts currently exist regarding both factors. Knowledge of the current prevalence (accounting for socioeconomic factors and age) is important for the selection of suitable detection methods, as this influences the positive and negative predictive value of the respective diagnostic methods. Current data on antibiotic resistance are essential for efficient therapy. In this clinical study, we will collect data on the frequency and severity of H. pylori infections and then, after endoscopic examination, on antibiotic resistance. Knowledge of the resistance situation is necessary for the selection of suitable therapeutic regimens. Furthermore, molecular methods for resistance detection are to be compared with conventional microbiological methods in order to be able to detect resistance more quickly. Furthermore, we aim to identify specific parameters for early detection of patients at particularly high risk of gastric cancer or with precancerous lesions due to infection. The aim is to identify carcinogenesis-relevant factors such as gastric microbiome signatures that will make it possible to identify patients who are most likely to benefit from prophylactic eradication therapy in terms of risk stratification.

Infection with H. pylori occurs in childhood and usually leads to lifelong persistence of the pathogen. The prevalence of the infection depends on socioeconomic status (occupation, income, housing situation), especially during childhood, when the transmission occurs most frequently. H. pylori infections are most common in East Asia, e.g. China, with prevalence rates of around 60-80 %, and in Africa, with prevalence rates of partly over 80 %. In Europe, there is a south-north divide in infection rates with a higher prevalence in southern countries. The prevalence in Germany varies between 21% for the Hannover area and 44% for Saxony-Anhalt; the prevalence in children is significantly lower than in adults. Current data on the larger population in Germany are lacking. While antibiotics in combination with PPIs can be used to treat the infection, rising antibiotic resistance rates reduce effectiveness of eradication regimens.

We therefore initiated a multicenter observational study to assess the prevalence of H. pylori infection and antibiotic resistance rates in Germany. In Part A, volunteers are screened for H. pylori infection by serology. If the test is positive, a breath test is performed for confirmation and further visits and examinations follow for long-term observation. Positive patients undergoing endoscopy can enter Part B, in which biopsies are taken for antibiotic resistance, and establishment of a serum, stool and a tissue bank for molecular analysis including microbiome sequencing.

Part A - Primary study objectives - screening phase The primary aim of this part of the study is to collect data on the prevalence of H. pylori in an age- and gender-stratified random sample of the populations of Munich, Tübingen, Hannover, Regensburg, and Magdeburg and their respective surroundings. If the initial serologic test is negative, no further study visits are planned for these subjects. The serum samples already collected will be used as control samples for the serologic study. If the serologic test is positive, a breath test is performed for confirmation. If the confirmatory breath test is positive and the subject is evaluated by his/her primary doctor and deemed a candidate for endoscopic evaluation, then s/he is referred for participation in part B of the study.

Part B - Secondary study objectives - investigation phase

As secondary study objectives, the following should be investigated in H. pylori infected study participants:

* Establishment of a patient cohort for long-term observation (5-10 years).
* Establishment of a serum, stool and tissue bank in this cohort for subsequent testing:

  * H. pylori subtype determination for gastric cancer risk, early detection via antibody responses in serum, identification of risk factors
  * PCR or sequencing of H. pylori strains (from stomach biopsy or stool sample)
  * H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies, only to be performed as part of a clinically indicated esophago-gastro- duodenoscopy - ÖGD (for diagnosis before initiation of therapy or also after completion of therapy to monitor success or progression)
  * Correlation of microbiological findings with histopathological findings and atrophy markers.
* Determination of H. pylori associated microbiome characteristics and microbiome changes after eradication therapy

Only patients undergoing gastroscopy for clinical indications are included into Part B of the study

blood samples, fecal samples, gastric biopsies

Helicobacter Pylori Local Prevalence and Antibiotic Resistance

HelicoPTER - Bestimmung Der Lokalen Helicobacter Pylori Prävalenz Und Antibiotika Resistenzlage

Prevalence of H. pylori infection in a random sample of the populations of Munich, Tübingen, Hannover, Regensburg, Magdeburg and their respective surroundings

H. pylori isolation and antibiotic resistance testing from gastric mucosa biopsies

H. pylori subtype determination via antibody responses in serum and sequencing of H. pylori strains

survey-based follow up of participants at 5 and 10 years for subsequent medical conditions

Correlation of microbiological and serological findings with gastric histopathology and subsequent cancer diagnoses

Technical University of Munich

Wounds and Injuries

Surgical Wound Infection

Surgical Wound

Wound Infection

Postoperative Complications

Vancomycin

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Cefuroxime

Cefuroxime axetil

Cephalosporins

Gentamicins

The standard prophylaxis consists of one to three intravenous doses of cefuroxime 1.5 g intravenously; or cefuroxim 3g if obesity \> 120 kg or a BMI \> 35 kg/m2; or vancomycin 1 g or clindamycin 600 mg in case of intolerance to cephalosporins

In patients alrady under current therapuetic antibiotic therapy, continuation of that therapuetic antibiotic regimen

Additional single-shot perioperative antibiotic prophylaxis with Broad-spectrum prophylaxis: vancomycin 1 g \& gentamicin 5 mg/kg.

One to three intravenous doses of cefuroxime 1.5 g intravenously; or 3g if obesity; or vancomycin 1 g or clindamycin 600 mg; if allergy. Continuation of eventual current therapeutic antibiotc regimens for any infection

Standard antibiotic prophylaxis

Ilker Uçkay, Professor

Mazda Farshad, Professor

The perioperative antibiotic prophylaxis is evidence-based in orthopedic surgery. While its duration ranges from a single dose to three doses throughout the world, the choice of the prophylactic agents is undisputed. Worldwide, the surgeons use 1st or 2nd-generation cephalosporins (or vancomycin in some cases).

However, there are particular clinical situation with a high risk of antibiotic-resistant surgical site infections (SSI); independently of the duration of adminis-tered prophylaxis. These resistant SSI's occur in contaminated wounds, or during surgery under current therapeutic antibiotics, and base on "selection" by antibiotics used for therapy or for prophylaxis.

The perioperative antibiotic prophylaxis is evidence-based for the majority of orthopedic surgeries. While the debate of its duration and timing (single-dose versus triple-dose; before or after the intraoperative microbiological sampling) may continue, no clinicians doubt on the efficiency of the recommended prophylactic agents; that are mostly 1st or 2nd-generation cephalosporins, co-amoxiclav or other exceptional agents in cases of (pseudo)-allergy. However. and traditionally, up to the half of all detected pathogens of orthopedic SSI's are not covered by the prior prophylactic regimens: e.g. SSIs due to methicillin-resistant cocci or non-fermenting Gram-negative rods in orthopedic surgery.

Additionally, orthopedic surgeons operating selected patient populations (neoplasms, open fractures, postoperative wound dehiscence9, diabetic foot infections or already infected body sites) experience a high risk of prophylactic-resistant pathogens, or pathogens resistant to current therapeutic antibiotics regimens. At least 10% of all new intraoperative tissue samples, during iterative surgical debridement, yield (new) pathogens unknown to the clinicians.

This is due to selection by prophylactic or therapeutic antibiotics, which only kill the previously detected pathogens, but left over newly introduced contaminants, remnant parts of partially-diagnosed polymicrobial infections; ultimately leading to a new SSIs occurring during therapy for the first infection at the orthopedic site. This selection is unpredictable involving both Gram-positive skin pathogens as well as (multi) resistant Gram-negative rods.From a microbiological point of view, only a maximal Gram-negative coverage, alongside with a large Gram-negative coverage, would cover these selections.

The literature is in-existing how to prevent these selections. Most clinicians just continue with the standard prophylactic recommendation, or the current thera-peutic antibiotic regimen. Theoretically, clinicians cannot exclude that these selected patient populations eventually might profit from a broad-spectrum prophylaxis.

The BAPTIST trials only concern the perioperative antibiotic prophylaxis in selected situations of orthopedic surgery: tumor surgery, debridement for postoperative dehiscent wounds, debridement under antibiotics, open fractures, skin colonization with multidrug-resistant bacteria, plus, as a control; spine surgery in selected multimorbid patients. The investigators alternately randomize the standard prophylaxis (or by continuing the current antibiotic treatment) to the additional broad-spectrum single-shot of vancomycin 1g IV \& single-shot of gentamicin 5 mg/kg intravenously; before an eventual intraoperative sampling. End-of-Treatment (EOT) and/or Test-of-Cure (TOC) occur latest at the 6-week's surgical control visit. The rest of the hospital stay, treatment, the use of negative-pressure vacuum therapy, other interventions, local antibiotic therapies; therapies or procedure are at the discretion of the treating clinicians.

The investogators will randomize surgical interventions defined by the inclusion criteria in a prospective-alternating scheme (1:1) according to the scheduled position in the operating theatres. The anesthetists (or the nurses at the hospitalization units) the will administer the standard prophylaxis (or the therapeutic antibiotics) alone, or with the addition of the single-shot broad-spectrum prophylaxis regimen composed of vancomycin and gentamicin. In case of clinical suspicion of infection or massive contamination, the surgeons will perform at least three microbiological intraoperative tissue samples. Each surgery counts as an independent event. If a patient is debrided several times, he/she can have different prophylaxis regimens during each of the interventions. After the prophylactic regimen, the clinicians are free to continue with a targeted or empirical therapeutic antibiotic regimen. The antibiotic therapy per se is not an objective of this current trials.

The treatment period includes the following daily study visits:

* Visit 1 - Enrollment (Day 1)
* EOT (end of microbiological cultures) - Day 14 (+/- 3 days)
* TOC (clinical surgical control) - Day 42 (+/- 14 days)
* Follow-up (telephone) for implant-related surgery - 1 year (+/- 2 months)

At enrollment (Day 1), the investigator will prescribe the preoperative antibiotic prophylaxis based on instructions provided in the protocol according to the patient's randomization. Patients will be randomized in the ratio 1:1 into the investigational group (broad-spectrum prophylaxis) and the control group (usual prophylaxis). Each patient can be included several times with one episode for each surgical interven-tion in the operating theatre. The initial consent form is valid during 1 month and will be renewed in case of another inclusion following a delay of 1 month after the initial signature of the patient.

The microbiologists culturing the pathogens of eventual surgical site infections are blinded to the prior prophylaxis during the index surgery

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Sur-gery - the Prospective-randomized, Microbiologist-blinded, Stratified, Superiority Trials - BAPTIST Trials

The investigators might share anonomyzed key elements (data) upon scientific request to the corresponding person

Assessment of SSI at the clinical controls according to clinical criteria in the literature (pus, discharge, pain, inflammation, several deep tissue microbiological cultures

Assessments of antibiotic resistance of pathogens according to standard susceptibilty testing in the Microbiological Laboratory

Unplanned revision surgery in the operating theatre for any reasons

Asssesment in the medical files. Have therapeutic antibiotics been changed according to new intraoperative bacterial culture findings

If there is therapeutic antibiotc treatment necessary, the investigators assess the drugs, the adverse events and the global costs related to the antibiotc treatment. The costs are the global (overall) hospitalizations costs in Swiss Francs.

Assessment of all nosocomial and community-acquired infections ocrruging in the immediate postoperative period and relate them to prior perioperative antibiotic prophylaxis

Assessment of the impact of the priorantibiotic prophylaxis on the body colonization with multiresistant bacteria of concern for infection control

Balgrist University Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Diarrhea

Prostatic Hyperplasia

Hyperplasia

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Signs and Symptoms, Digestive

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Antineoplastic Agents

Levofloxacin

Ofloxacin

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.

Koenraad van Renterghem, PhD

To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or \> 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.

Main objective:

To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or \> 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).

Secondary objective:

To investigate post-operative bacteriuria after TURB and TURP in our population.

Principal inclusion criterium:

Patients undergoing TURP or TURB.

Primary exclusion criterium:

TURP: pre-operative catheter or \> 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).

Primary endpoint:

Post-operative infection.

Secondary endpoint:

Post-operative bacteriuria.

Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)

A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

Urosepsis, fever (t°\> 38.5) or epididymitis.

Jessa Hospital

Sheena Mukkada, MD

Antibiotic resistance is one of the major health threats facing global as well as domestic populations, however it is not well characterized in pediatric patients. Pediatric patients receiving cancer-directed therapy have several risk factors implicated in development of antibiotic resistance including multiple courses of antibiotics, repeated exposures to the hospital environment, indwelling devices and chemotherapy-related damage to mucosal barriers. The investigators propose to capitalize upon the unique position of St. Jude Global within the global pediatric oncology community by using its regional alliance network to describe the molecular epidemiology of antibiotic resistance in Gram-negative bacteria in this population.

Primary Objectives

1. Describe the epidemiology and the phenotypic and previously determined molecular determinants of antimicrobial resistance in Gram-negative organisms isolated from pediatric diagnostic specimens in selected Central American and US sites with capacity to treat pediatric cancer
2. Utilize strain typing by whole genome sequencing to describe relatedness between organisms at participating sites

Participating clinical microbiology laboratories will flag any Gram-negative bacteria meeting inclusion criteria. Bacteria will be subcultured; one sample will be lysed and shipped to St. Jude; the remaining sample will be stored onsite for the duration of the study. Samples of bacteria from both oncology and non-oncology patients will be included. Whole genome sequencing will be performed on the bacterial samples at St. Jude and the genotypic and phenotypic antimicrobial resistance testing (AST) results compared. Genotypic results will additionally be used to describe phylogenetic relationships and potential transmission events both within and between sites.

Each participating location will collect limited clinical data corresponding to disease and treatment related factors on the affected patient. This will include sociodemographic variables, oncologic diagnosis, treatment phase, presence of a central venous catheter or other foreign body, antibiotic treatment within the past month, and previous history of colonization or infection by a resistant organism.

Antibiotic Resistance in Global Pediatric Oncology Centers

Number of isolated organisms by anatomic site and geographic site

Number of antibiotic resistance genes/mutations of interest by geographic site

Correlation of known mutations/genes of interest with drug resistance phenotype

Whole genome sequencing results will be used to describe whether isolated organisms appear to be related phylogenetically.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Helicobacter Pylori Local Prevalence and Antibiotic Resistance	NCT05561504	Helicobacter Py... Helicobacter Py... Drug Resistant ... Antibiotic Resi... Gastric Cancer Microbial Colon...		18 Years -	Technical University of Munich
Helicobacter Pylori Local Prevalence and Antibiotic Resistance	NCT05561504	Helicobacter Py... Helicobacter Py... Drug Resistant ... Antibiotic Resi... Gastric Cancer Microbial Colon...		18 Years -	Technical University of Munich
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	NCT05502380	Surgical Site I... Microbial Colon... Antibiotic Resi...	Standard antibi...	18 Years -	Balgrist University Hospital
Helicobacter Pylori Local Prevalence and Antibiotic Resistance	NCT05561504	Helicobacter Py... Helicobacter Py... Drug Resistant ... Antibiotic Resi... Gastric Cancer Microbial Colon...		18 Years -	Technical University of Munich
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)	NCT04212403	Urosepsis Bladder Cancer Prostate Hyperp... Antibiotic Resi... Antibiotic Resi... Antibiotic-asso... Antibiotic Toxi...	Levofloxacin	18 Years -	Jessa Hospital
Antibiotic Resistance in Global Pediatric Oncology Centers	NCT03721562	Antibiotic Resi...		- 18 Years	St. Jude Children's Research Hospital
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	NCT05502380	Surgical Site I... Microbial Colon... Antibiotic Resi...	Standard antibi...	18 Years -	Balgrist University Hospital

Spots Global Cancer Trial Database for antibiotic resistant infection