Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Persistent MRSA Eradication Protocol (PMEP)
Brief Summary: The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade. Evidence suggests that persistent infection with MRSA may result in an increased rate of decline in Forced Expiratory Volume (FEV)1 and shortened survival. Currently there are no conclusive studies demonstrating an effective aggressive treatment protocol for persistent MRSA respiratory infection in CF. Data demonstrating an effective and safe method of clearing persistent MRSA infection are needed.

The purpose of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation, 250 mg twice a day, (in combination with oral antibiotics) in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. Subjects will be assigned in a 1:1 ratio to either vancomycin for inhalation (250 mg twice a day) or taste matched placebo and will be followed for 3 additional months. In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP-SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled in this trial.


Options:
A: 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
B: 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
C: 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])
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: D