LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection

06:18 EDT 1st October 2014 | BioPortfolio

Summary

The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis.

The secondary endpoints are:

- To assess the rate of clinical failure 12 months after the reimplantation of the prosthesis.

- To assess the joint mobility function score 12 months after the reimplantation of the prosthesis.

- To assess the safety of the combination of levofloxacin and rifampicin.

- To investigate prognostic factors for success after the end of treatment and at 12 months after the reimplantation of the prosthesis.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Infection

Intervention

Levofloxacin (HR355) and Rifampicin Therapy

Location

Sanofi-Aventis Administrative Office
Paris
France

Status

Terminated

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Clinical Trials [259 Associated Clinical Trials listed on BioPortfolio]

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PubMed Articles [15274 Associated PubMed Articles listed on BioPortfolio]

Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial.

We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis (TBM).

Levofloxacin and proton pump inhibitor-based triple therapy versus standard triple first-line therapy for Helicobacter pylori eradication.

Standard triple therapy for Helicobacter pylori infection fails in up to one quarter of patients. Levofloxacin-based triple therapy may be more efficacious.

Treatment of Helicobacter pylori infection: Current status and future concepts.

Helicobacter pylori (H. pylori) infection is highly associated with the occurrence of gastrointestinal diseases, including gastric inflammation, peptic ulcer, gastric cancer, and gastric mucosa-associ...

Therapeutic Drug Monitoring and Pharmacogenetic Study of HIV-Infected Ethnic Chinese Receiving Efavirenz-Containing Antiretroviral Therapy with or without Rifampicin-Based Anti-Tuberculous Therapy.

Plasma efavirenz concentrations in HIV-infected patients with tuberculosis (TB) may be affected by cytochrome P450 (CYP) 2B6 single-nucleotide polymorphisms and concurrent rifampicin use. We aimed to ...

Qilin pills combined with levofloxacin for asthenospermia accompanied with accessory sex gland infection: a clinical observation.

To observe the efficacy of the combination of Qilin Pills and levofloxacin in the treatment of asthenospermia accompanied with accessory sex gland infection.

Medical and Biotech [MESH] Definitions

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.

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Defective metabolism leading to fat maldistribution in patients infected with HIV. The etiology appears to be multifactorial and probably involves some combination of infection-induced alterations in metabolism, direct effects of antiretroviral therapy, and patient-related factors.

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