Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)
Brief Summary: Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA.

Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit.

Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.


Options:
A: 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
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: 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: 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

Answer: D