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| Name | Class |
|---|---|
| Vaincre la Mucoviscidose | OTHER |
| GlaxoSmithKline | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
| Roche Pharma AG |
The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.
Each patient received two successive IV antibiotic courses during a period of pulmonary exacerbation. One of these courses was delivered as thrice daily 30-minute infusions of ceftazidime in 100 ml of 0.9% sodium chloride, and the other was delivered as a continuous infusion of ceftazidime in 230 ml of 0.9% sodium chloride, over 23 hours. The daily dose of ceftazidime was 200 mg/kg, with a maximum dose of 12 g. For ceftazidime continuous infusion, a loading dose of 60 mg/kg (maximum 2 g) was used. All patients also received tobramycin (10 mg/kg), in the form of one 30-minute infusion per day. Portable devices were used: Intermate® SV 200 (Baxter) for the 30-minute short infusions of ceftazidime and tobramycin, Infusor® LV10 (Baxter) for continuous infusion of ceftazidime.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftazidime | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forced expiratory volume in 1s (FEV1) between the beginning and the end of the IV antibiotic course, expressed as a percentage of the predicted normal value |
| Measure | Description | Time Frame |
|---|---|---|
| the interval between 2 successive IV antibiotic courses | ||
| quality of life scores | ||
| sputum collected at the beginning and the end of each antibiotic course |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Hubert, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble | Grenoble | 38043 | France | |||
| Centre hospitalier Dr Schaffner |
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| INDUSTRY |
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| plasma ceftazidime concentration at steady state (Css) for ceftazidime continuous infusion, and before (C trough), 30 minutes (Cmax) and 4 hours after (C4) the beginning of ceftazidime short infusion |
| C-reactive protein, leukocytes and hepatic enzymes levels at the beginning and the end of each IV antibiotic course |
| Lens |
| 62307 |
| France |
| Hopital Albert Calmette | Lille | 59000 | France |
| Hopital Jeanne de Flandre | Lille | 59000 | France |
| Hopital Sainte Marguerite | Marseille | 13000 | France |
| Assistance Publique des hopitaux de paris, Hopital Trousseau | Paris | 75012 | France |
| Assistance Publique des Hopitaux de Paris, Hopital Cochin | Paris | 75014 | France |
| Assistance Publique des Hopitaux de Paris, Hopital Necker | Paris | 75015 | France |
| Assistance Publique des Hopitaux de Paris, Hopital Robert Debré | Paris | 75019 | France |
| Hopital Sud | Rennes | 35056 | France |
| Centre Héliomarin | Roscoff | 29684 | France |
| Hopital Hautepierre | Strasbourg | 67000 | France |
| Hopital Foch | Suresnes | 92150 | France |
| Hopital Larrey | Toulouse | 31000 | France |
| Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002442 | Ceftazidime |
| ID | Term |
|---|---|
| D002509 | Cephaloridine |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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