STAph Aureus 저항성 - 조기 치료 및 반복(STAR-TER) (STAR-TER)

피험자는 경구 항생제 1종, 국소 항생제 1종, 구강 헹굼제로 치료를 받고 환경 오염 제거 기술을 사용하도록 지시받습니다.

Trimethoprim Sulfamethoxazole(TMP/SMX)은 사용되는 주요 경구 항생제입니다. TMP_SMX에 대한 알레르기 또는 과민증이 있는 피험자는 대체 항생제로 미노사이클린을 사용합니다. 국소 항생제는 비강 Mupirocin과 0.12% chlorhexidine gluconate가 함유된 구강 헹굼/거글입니다.

40kg 미만인 경우 투여: 8mg/kg 트리메토프림/40mg/kg 트리메토프림 설파메톡사졸을 1일 2회, 1-14일 및 29-42일 동안 14일 동안 매일 투여합니다.

투여량은 40kg 이상입니다: 320mg/1600mg을 1일 2회, 1-14일 및 29-42일 동안 14일 동안.

• 박트림
• 셉트라

피험자가 TMP/SMX에 대한 알레르기 또는 불내성이 있는 경우, 8세 이상인 경우 미노사이클린으로 치료할 수 있습니다.

50kg 미만인 경우 투여: 1-14일 및 29-42일 동안 14일 동안 1일 2회 2 mg/kg 경구 투여.

≥ 50 kg인 경우 투여: 1-14일 및 29-42일 동안 14일 동안 1일 2회 100 mg.

• 미노신
• 다이나신
• 솔로딘
• Cleeravue-M
• 벡트린

• 박트로반
• 센타니

• 다이나-헥스

피험자는 1-21일 및 29-49일 동안 매일 표면 소독 물티슈로 접촉이 많은 모든 표면과 의료 장비를 닦도록 지시받습니다.

피험자는 또한 1-3주 및 5-7주 동안 매주 1회 뜨거운 물로 모든 리넨과 수건을 세탁하도록 지시받을 것입니다.

• Sani-Cloth 물티슈

Pulmonary exacerbation is defined as having 1 of the major criteria or 2 minor signs/symptoms and fulfillment of symptom duration.

Major criteria:

1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry)
2. Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
3. New lobar infiltrate(s) or atelectasis on chest radiograph
4. Hemoptysis (more than streaks on more than one occasion in past week)

Minor signs/symptoms:

1. Increased work of breathing or respiratory rate
2. New or increased adventitial sounds on lung exam
3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
4. Increased cough
5. Decreased exercise tolerance or level of activity
6. Increased chest congestion or change in sputum

Signs/symptoms duration: initial symptom must have occurred for at least 5 days.

Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration.

Major criteria:

1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry)
2. Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
3. New lobar infiltrate(s) or atelectasis on chest radiograph
4. Hemoptysis (more than streaks on more than one occasion in past week)

Minor signs/symptoms:

1. Increased work of breathing or respiratory rate
2. New or increased adventitial sounds on lung exam
3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
4. Increased cough
5. Decreased exercise tolerance or level of activity
6. Increased chest congestion or change in sputum

Signs/symptoms duration: initial symptom must have occurred for at least 5 days.

Pulmonary exacerbation is defined as having 1 of the major criteria or 2 of the minor signs/symptoms and fulfillment of symptom duration.

Major criteria:

1. Absolute decrease in FEV1 of ≥ 10% from Visit 1 (Baseline), unresponsive to albuterol (in participants able to reproducibly perform spirometry)
2. Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
3. New lobar infiltrate(s) or atelectasis on chest radiograph
4. Hemoptysis (more than streaks on more than one occasion in past week)

Minor signs/symptoms:

1. Increased work of breathing or respiratory rate
2. New or increased adventitial sounds on lung exam
3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
4. Increased cough
5. Decreased exercise tolerance or level of activity
6. Increased chest congestion or change in sputum

Signs/symptoms duration: initial symptom must have occurred for at least 5 days.

Pulmonary exacerbation defined as having 1 of the major criteria or 2 of the minor signs/symptoms. Pulmonary exacerbations recorded as number of exacerbations across all participants.

Major criteria:

1. Absolute decrease in FEV1 ≥10% from Visit 1, unresponsive to albuterol (in participants able to perform spirometry)
2. Oxygen saturation <90% on room air or absolute decrease of ≥ 5% from Visit 1
3. New lobar infiltrate(s) or atelectasis on chest radiograph
4. Hemoptysis (more than streaks on more than one occasion in past week)

Minor signs/symptoms:

1. Increased work of breathing or respiratory rate
2. New or increased adventitial sounds on lung exam
3. Weight loss ≥5% of body weight or decrease across 1 major percentile in weight percentile for age in past 6 months
4. Increased cough
5. Decreased exercise tolerance or level of activity
6. Increased chest congestion or change in sputum

Signs/symptoms duration: initial symptom must have occurred for at least 5 days.