A double blind, randomized, placebo-controlled study to evaluate the antiviral activity, safety and plasma pharmacokinetics of multiple intravenous doses of TMC353121 in hematopoietic stem cell transplant subjects (autologous and allogeneic) with evidence of upper respiratory tract infection (URTI) caused by the respiratory syncytial virus (RSV)

INTERVENTION: Product Name: TMC353121 Product Code: R391036 or JNJ‐27387581‐AAA, formulation F002 Pharmaceutical Form: Solution for infusion INN or Proposed INN: N.A CAS Number: N.A Current Sponsor code: TMC353121 (R391036) Other descriptive name: JNJ‐27387581‐AAA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Respiratory Synctycial Virus (RSV) PRIMARY OUTCOME: Main Objective: The primary objective of the trial is to estimate the antiviral activity and safety of a 7‐day dosing regimen with 0.5 mg/kg/2h/day of TMC353121 in RSV infected post‐stem cell transplant subjects having URTI. Primary end point(s): ‐ estimation of the antiviral activity and safety of TMC353121; ‐ measurement of levels of TMC353121 in plasma for evaluation of PK parameters; ‐ evaluation of nasopharyngeal washings + aspirates for resitance testing; ‐ measurement of RSV viral titer in nasopharyngeal washings + aspirates; ‐ immunologic value and change, measured by RSV‐IgA; ‐ adverse events inquiry, vital signs, 12‐lead ECG, lung function testing (spirometry, peak expiratory flow, peripheral O2 saturation), performance status, hematology and coagulation, biochemistry, urinalysis Secondary Objective: ‐ To evaluate safety parameters of both local and systemic toxicity.; ‐ To evaluate severity of clinical signs of URTI (such as rhinitis with nasal discharge,; rhinitis with nasal obstruction, sore throat, laryngitis, pharyngitis, otitis media, sinusitis) and LRTI (wheezing, dyspnea, increased sputum production, increased respiratory rate, pulmonary infiltration, fever) over time.; ‐ To evaluate progression of URTI to LRTI: 28‐day mortality incidence, morbidity, days; of hospitalization, days in ICU, length of O2 therapy, lung function (spirometry) and; chest X ray.; ‐ To document the plasma concentration profile of multiple intravenous doses of; TMC353121 on Days 7 to 9, and to assess the time to reach steady‐state plasma levels.; ‐ To evaluate the general health condition including cGVHD and Karnofsky performance status. INCLUSION CRITERIA: 1. Subject in post‐engraftment status of autologous or allogeneic transplantation, with URTI, with nasopharyngeal washings/aspirates positive for RSV, diagnosed locally. Diagnosis of URTI will be considered when in the absence of LRTI diagnosis, at least 1 of the following symptoms is present: rhinitis with nasal discharge, rhinitis with nasal obstruction, sore throat, laryngitis, pharyngitis, otitis media, sinusitis. Diagnosis of LRTI will be considered when at least 1 of the following symptoms is present: wheezing, dyspnea, increased sputum production, increased respiratory rate, pulmonary infiltration (based on chest X‐ray, at the discretion of the investigator), fever (in the presence of at least 1 other LRTI related symptom). 2. Subject between 18 and 65 years, extremes included. 3. Informed Consent Form signed voluntarily. 4. Subject agrees to use a reliable double barrier birth control method for the duration of the study. Are the trial sub