Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)

Официальное название

Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])

Обзор

The goal of this clinical trial is to determine if a "watch and wait" antibiotic strategy, called Safety Net Antibiotic Prescribing (SNAP), can safely reduce unnecessary antibiotic use while ensuring that children diagnosed with community-acquired pneumonia get better from their illness. The main aims of this study are: * To compare the effectiveness of SNAP versus immediate antibiotic prescribing in children with mild community-acquired pneumonia (CAP) * To identify which patient groups benefit most from the SNAP strategy * To identify factors that shape implementation of each prescribing strategy. Researchers will compare the SNAP strategy (where parents or guardians are instructed to give antibiotics only if their child is not improving after 72 hours, or sooner if they are worsening) to the immediate antibiotic prescribing strategy (where parents or guardians are instructed to give the antibiotics right after their healthcare visit) to see if one strategy is more effective than the other. Participants will be randomly assigned to either the immediate antibiotic group or the SNAP group at enrollment. Participation lasts 14 days with follow-up surveys at 4, 7, and 14 days after enrollment.

Подробное описание

This study is a multicenter, Hybrid Type-1effectiveness-implementation randomized clinical trial (RCT) designed to evaluate the effectiveness of a "Safety Net Antibiotic Prescribing" (SNAP) strategy versus an immediate antibiotic prescribing strategy for young children 12 months to \<6 years of age with community-acquired pneumonia (CAP) who are treated as outpatients.

This study will recruit eligible patients from approximately 19 clinical sites consisting of pediatric emergency departments (EDs), primary care offices, and urgent care centers within the United States and enroll up to 2,000 patients. Patient recruitment will occur over a 3.5-year period. Participants will be identified and screened during routine visits at the clinical sites.

Through an online system, participants will be randomized to either the immediate antibiotic group or the SNAP group. All participants will receive a prescription for antibiotics as per usual care from their treating clinician.

The parents or guardians of the participants will be asked to complete an online survey on Days 4 and 14 (+/- 2 days) to collect data for the secondary outcomes, including quality of life, satisfaction, and return visits. On Day 7 (+/- 2 days), the parents or guardians of the participants will be contacted by phone to collect data for the primary outcome, focusing on clinical improvement and antibiotic use.

Acceptability and feasibility will be assessed with parent or guardian and clinician surveys and interviews. Parents or guardians will be surveyed at Day 14 and a subset will be invited for interviews within a month of the final follow-up visit. Clinicians will be surveyed, and a subset will be interviewed at the conclusion of the trial.

Вмешательства

• Другое Immediate Antibiotic Prescribing Group Instructions
  Children randomized to the immediate antibiotic prescribing group will receive an antibiotic prescription with instructions to fill and administer the antibiotics.
• Другое Safety Net Antibiotic Prescribing (SNAP) Group Instructions
  For children randomized to the SNAP group, their parents or guardians will receive a prescription for antibiotics, but will be told not to administer the antibiotic unless their child's symptoms show no improvement at 72 hours or worsen within 72 hours.

Первичные конечные точки

• Clinical Improvement [Срок оценки: From enrollment to day 7]
• Antibiotic Use [Срок оценки: From enrollment to day 7]

Вторичные конечные точки (5)

• Antibiotic Exposure [Срок оценки: From enrollment to day 14]
• Clinical Improvement [Срок оценки: From enrollment to day 14]
• Parent Satisfaction [Срок оценки: From enrollment to day 14]
• Quality of Life Measures [Срок оценки: From enrollment to day 14]
• Return to Care [Срок оценки: From enrollment to day 14]

Критерии участия

Критерии включения

• Aims 1 and 2:
• Presenting with signs and symptoms of lower respiratory tract infection
• Diagnosed with community-acquired pneumonia (CAP) by a clinician
• The treating clinician intends to prescribe antibiotics for CAP, AND
• Well enough, as determined by the clinician at the time of the study enrollment visit, to be managed as an outpatient.
• Aim 3:
• Parent/guardian of child enrolled in the trial, OR
• Clinician who makes prescribing decision at the study site, OR
• Other practice-based parties (e.g. nurses, pharmacists, medical assistants, practice leaders) at study sites who can comment on the implementation of each prescribing strategy.

Критерии исключения

• Aims 1 and 2:
• Hospitalization within the previous 7 days
• Oxygen saturation below 90%, if measured
• Incomplete immunization status (e.g., lacking at least 3 doses of the pneumococcal vaccines, typically given as part of the 2-, 4-, and 6-month vaccinations)
• Chronic medical conditions that increase the risk of bacterial CAP (e.g., chronic lung disease, cystic fibrosis, sickle cell disease),
• Substantially immunocompromised status (e.g., immunodeficiency, active cancer treatment, organ transplant with concurrent immunosuppressive agents)
• Receipt of oral or parenteral antibiotics within the previous 7 days
• Diagnosis of complicated pneumonia (e.g., empyema, lung abscess)
• Known bacterial source of infection warranting immediate antibiotics
• Pneumonia diagnosis within the previous 6 months, OR
• Prior enrollment in the trial
• Inability of the parent or guardian to speak English or Spanish
• Aim 3:
• Inability of the parent or guardian to speak English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 4 центра

• Children's Healthcare of Atlanta — Atlanta
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• Children's Hospital of Philadelphia — Philadelphia
• Primary Children's Hospital — Salt Lake City

Идентификаторы

NCT: NCT06986148 · IRB_00185848 · BPS-2023C3-35456

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗