Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: MP-376 120 mg QD; Type: EXPERIMENTAL; Interventions: Drug: MP-376 | Arm Label: MP-376 240 mg QD; Type: EXPERIMENTAL; Interventions: Drug: MP-376 | Arm Label: MP-376 240 mg BID; Type: EXPERIMENTAL; Interventions: Drug: MP-376 | Intervention Type: DRUG; Name: MP-376; Assigned to Arm(s): MP-376 120 mg QD, MP-376 240 mg BID, MP-376 240 mg QD | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Drug: Rifampin, Drug: Trimethoprim/Sulfamethoxazole, Drug: Minocycline, Drug: Mupirocin, Drug: chlorhexidine gluconate oral rinse, Drug: 2% Chlorhexidine solution wipes, Behavioral: Environmental Decontamination | Arm Label: Observational; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Rifampin; Assigned to Arm(s): Treatment | Intervention Type: DRUG; Name: Trimethoprim/Sulfamethoxazole; Assigned to Arm(s): Treatment | Intervention Type: DRUG; Name: Minocycline; Assigned to Arm(s): Treatment | Intervention Type: DRUG; Name: Mupirocin; Assigned to Arm(s): Treatment | Intervention Type: DRUG; Name: chlorhexidine gluconate oral rinse; Assigned to Arm(s): Treatment | Intervention Type: DRUG; Name: 2% Chlorhexidine solution wipes; Assigned to Arm(s): Treatment | Intervention Type: BEHAVIORAL; Name: Environmental Decontamination; Assigned to Arm(s): Treatment
D: Arm Label: Inhaled Vanc and Oral Abx; Type: EXPERIMENTAL; Interventions: Drug: Inhaled Vancomycin, Drug: Rifampin, Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX), Drug: Doxycycline, Drug: Mupirocin Intranasal Creme, Drug: 4% chlorhexidine gluconate liquid skin cleanser | Arm Label: Inhaled Placebo and Oral Abx; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo (Sterile Water), Drug: Rifampin, Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX), Drug: Doxycycline, Drug: Mupirocin Intranasal Creme, Drug: 4% chlorhexidine gluconate liquid skin cleanser | Intervention Type: DRUG; Name: Inhaled Vancomycin; Assigned to Arm(s): Inhaled Vanc and Oral Abx | Intervention Type: DRUG; Name: Placebo (Sterile Water); Assigned to Arm(s): Inhaled Placebo and Oral Abx | Intervention Type: DRUG; Name: Rifampin; Assigned to Arm(s): Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx | Intervention Type: DRUG; Name: Trimethoprim/Sulfamethoxazole (TMP/SMX); Assigned to Arm(s): Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx | Intervention Type: DRUG; Name: Doxycycline; Assigned to Arm(s): Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx | Intervention Type: DRUG; Name: Mupirocin Intranasal Creme; Assigned to Arm(s): Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx | Intervention Type: DRUG; Name: 4% chlorhexidine gluconate liquid skin cleanser; Assigned to Arm(s): Inhaled Placebo and Oral Abx, Inhaled Vanc and Oral Abx

Answer: B