Hospitalized male and female patients aged ≥ 18 years, suffering of Cystic Fibrosis.

Cystic Fibrosis

Teicoplanin Sandoz administered by inhalation (aerosol).

Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution.

Centro Ricerche Cliniche di Verona - Azienda Ospedaliera Universitaria Integrata di Verona

Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

An Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the sputum of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time points after first inhalation: 0 hours, 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the blood of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time points after first inhalation: 0 hours, 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the urine of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time intervals after first inhalation: 0 hours, 0 - 4 hours, 4 - 12 hours, 12 - 24 hours. The evaluation of Teicoplanin pharmacokinetics will include calculation of Cmax (mg/L), Tmax (hours) and AUC0-12 h (μg/mL*h) starting from the obtained concentration (mg/L). In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time intervals will be measured for subsequent inhalations.

Comparison between the concentration (expressed as mg/L) of Teicoplanin measured in the sputum, blood and urine of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg versus additional dosage(s) of Teicoplanin, in case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin.

Measurement of any changes (as %) in the Forced Expiratory Volume in the 1st second (FEV1) measured 30 minutes before and 30 and 60 minutes after a single inhalation of 150 mg of inhaled Teicoplanin. In case of FEV1 reduction > 5% in comparison to baseline the FEV1 will be measured also after 120 minutes from inhalation. In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Measurement of any changes (as %) in the blood oxigen saturation measured 30 minutes before and 30 minutes + 4 hours after a single inhalation of 150 mg of inhaled Teicoplanin. In case a value of AUC0-12 h above 300 μg/mL*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations.

Evaluation of the number, rate and characteristics of the adverse events occurring to CF patients treated with inhaled Teicoplanin, as recorded in the Case Report Form. Any adverse events occurring during the inhalation visits will be also evaluated from a Tolerability point of view.

Neupharma Srl

Sintesi Research Srl

Aptuit Srl

Pari Pharma GmbH

Centro Ricerche Cliniche di Verona

Prospective, single-arm, exploratory, open-label, dose-escalation study evaluating the pharmacokinetics of inhaled Teicoplanin in Cystic Fibrosis patients.

Gemcitabine doses: 300 mg/m2/week for 6 weeks.

Cervical Cancer

Gemcitabine 300 mg/m2, prepared in 0.5 liters of sodium chloride 0.9%, IV administered in 30 minutes weekly for a maximum of 6 weeks.
Radiotherapy will start the first week, or as soon as the blood count is normal or the patient has recovered after blood transfusion. Radiotherapy will be applied, using an external beam releasing 40-50.4 Gy in 20-28 fractions: 1.8 Gy/day for 5 days/week, during 4 to 6 weeks.
Intracavitary brachytherapy will be added to reach a total EQD2 dosage (α/β=10) of 78-86 Gy.

Gemcitabine

National Institute of Cancer

Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

A Phase II Clinical Trial to Evaluate the Potential of Concomitant Chemoradiotherapy With Gemcitabine in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

Safety of gemcitabine regarding renal function will be assessed through glomerular filtration rate.
An improvement of 10 ml/min/1.73m2 as compared to basal glomerular rate is expected by the end of treatment.

Toxicity will be evaluated according to the toxicity criteria of CTCEA v. 4.03. A toxicity index of <4 is expected during treatment.

Dr. Lucely Cetina Pérez

MD, Master of Science

National Institute of Cancerología

Instituto Nacional de Cardiologia Ignacio Chavez

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Phase II open, single arm, national, non-randomized clinical trial; to evaluate safety of gemcitabine in patients with locally advanced cervical cancer and renal dysfunction, referring to the INCAN.

Crystalloids, any type of Crystalloids including isotonic or hypertonic saline, Ringer Lactates either modified or not

Colloids, including albumin, gelatines, starch any other synthetic colloids

Critical Illness

Isotonic or hypertonic saline or Ringer Lactate or any other crystalloids, at the necessary dose to restore hemodynamic for all ICU stay

Crystalloids

Gelatines, Albumine, Starch, or any other colloids, at the necessary dose to restore hemodynamic (starch cumulative daily dose should not exceed 35/40 ml/kg), for all ICU stay

Colloids

Any crystalloids given for correction of hypovolemia during all ICU stay

Any colloids given for correction of hypovolemia during all ICU stay

Hôpital Erasme

CHU de Sherbrooke-Höpital Fleurimont

Hôpital Charles LeMoyne

CH d'Angers

Centre Hospitalier d'Annecy

CH Joseph Imbert

CH d'Arpajon

CHG de Bastia

Hôpital Avicenne

CH Pellegrin Tripode

Hôpital Cavale Blanche

Chg Briancon

HIA Percy

Hôpital A. Beclere

Hôpital Corbeil Essonnes

Hôpital Henri Mondor

Hôpital Général

CH Dourdan

Centre Hospitalier d'Etampes

Hôpital de FREYMING-MERLEBACH

Hôpital Raymond Poincaré

Hôpital A. Mignot

CHU Liege

Hôpital Claude Huriez

CH Dupuytren

Centre Régional Léon Bernard

Hôpital Louis Pradel

CH MEAUX

Hôpital Saint Eloi

Centre Hospitalier de Mulhouse

Hôpital Central

Hôpital Central NANCY

Polyclinique de Gentilly

CHRG d'Orléans

HEGP

Hôpital Bichat Claude Bernard

Hôpital Bicêtre

Hôpital la Pitié Salpétrière

Hôpital Lariboisière

Hôpital Saint Louis

Hôpital TENON

Hôtel Dieu

CHU de Bordeaux

Chu Lyon Sud

CHI Poissy

CHU de Poitiers

Centre Hospitalier R. Dubos

CH Claude Galien

Chu Reims

CHU Rennes

CH Victor Provo

Hôpital Charles Nicolle

Centre Cardiologique du Nord

CHI Saint Germain en Laye

CH Mémorial SAINT LO

CHG de SOISSONS

Hôpital Civil

Hôpital Hautepierre

CHR Bel Air

CHU Toulouse

CHG Valence

CHU Brabois Nancy

Hôpital T Sfar

Chu Bourguiba

Hôpital A Mami

Homerton University Hospital

Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients

CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial

bronchial spasm/ألبيومين

Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients

Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

Efficacy and Safety of Colloids Versus Crystalloids for Fluid Resuscitation in Critically Ill Patients

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