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Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia (STAMPP)

Primary Purpose

Pneumonia, Pediatric Respiratory Diseases, Antibiotic Use

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Supportive Care + Amoxicillin
Supportive Care + Placebo (no antibiotics)
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Pediatrics, Pediatric CAP, Pediatric Pneumonia, Antibiotic Use

Eligibility Criteria

12 Months - 71 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 12-71 months; and Diagnosis of CAP, defined using established criteria: Signs and symptoms of lower respiratory tract infection (LRTI), defined as any of the following: new or different cough; or new or different sputum production; or chest pain; or dyspnea/shortness of breath; or documented tachypnea; or abnormal findings consistent with LRTI on physical examination (e.g., crackles/rales, rhonchi, wheezing) and Fever, defined as tactile temperature at home or measured temperature ≥38ºC rectal, ≥37.7ºC oral, or ≥37.5ºC axillary, and Clinician diagnosis of CAP, Intention to treat as an outpatient after ED/primary care visit, and Mild disease, defined as lack of respiratory distress per adapted Pediatric Infectious Diseases Society/Infectious Diseases Society of America criteria: none of the following: dyspnea, concerning retractions per treating clinician, grunting, nasal flaring, apnea, altered mental status, SpO2<93% in room air, or respiratory rate >50 breaths per minute for ages 12-24 months or respiratory rate > 40 breaths per minute if age>24 months. Exclusion Criteria: Hospitalization within one-month preceding study visit; or Incomplete immunization status (<2 doses of Hib and pneumococcal vaccines); or Chronic complex medical conditions (chronic heart disease followed by cardiology, chronic lung disease (not including asthma), congenital airway or lung malformations, cystic fibrosis, tracheostomy tube, requiring positive-pressure ventilation, neuromuscular disorders affecting the lungs or chest wall); or Conditions that compromise the immune system (HIV with CD4 count less than 400, primary immunodeficiency, asplenia, sickle cell disease, receipt of hematopoietic stem cell or solid organ transplant, cancer on active chemotherapy, immunosuppressive agents, daily corticosteroids for more than 7 consecutive days in past 14 days); or Systemic antibiotic receipt (more than 1 dose) within the previous two weeks of CAP diagnosis; or Radiographic findings of a consolidation of a concerning size or complexity in the view of the treating clinician; or Radiographic findings of complicated pneumonia (pleural effusion larger than trace in size, empyema, [complex/septated collection] abscess, necrotic lung disease); or Pneumonia known to be due to bacterial source at the time of enrollment, as documented by blood culture or PCR if available, or another clear source of bacterial infection requiring immediate antibiotics; or Diagnosed with pneumonia in the previous month; or Provider diagnosis of aspiration pneumonia; or Severe (type 1) drug allergy to amoxicillin; or Any other condition that in the judgement of investigators or the clinical team could affect safety of the subject; or No access to a telephone or video technology for follow-up; or Current enrollment in another clinical trial of an investigational agent; or Previous enrollment in this trial; or Parent/guardian non-English or non-Spanish speaking; or Known allergy to milk and/or red dye.

Sites / Locations

  • Ann & Robert H Lurie Children's Hospital of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Amoxicillin

Arm Description

Randomization to receive either oral placebo or amoxicillin for a standard course (7 days)

Randomization to receive either oral amoxicillin or placebo for a standard course (7 days)

Outcomes

Primary Outcome Measures

Enrollment Rate Per Month
Total number of participants enrolled divided by the total number of active enrollment months

Secondary Outcome Measures

Consent Rate
Number of eligible participants approached regarding trial participation who provided informed consent to participate in the trial compared with number of participants approached for participation
Lost to Follow-Up at Day 7
Number of enrolled participants who did not complete the Day 7 follow-up visit
Lost to Follow-Up at Day 21
Number of enrolled participants who did not complete the Day 21 follow-up visit

Full Information

First Posted
February 3, 2023
Last Updated
February 3, 2023
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05726253
Brief Title
Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia
Acronym
STAMPP
Official Title
Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
National guidelines make two recommendations for treatment of young children with mild pneumonia - one to avoid routine antibiotics and another to use narrow-spectrum antibiotics. No studies have compared the effectiveness of these two approaches. This pilot study will evaluate study processes and feasibility of a future clinical trial that proposes to test whether low-risk children managed as outpatients with mild community-acquired pneumonia (CAP) treated with supportive treatment without antibiotics will have a similar clinical response, with fewer adverse effects, compared with those treated with a supportive treatment plan that includes antibiotics.
Detailed Description
This pilot clinical trial is a randomized, placebo-controlled, double-blinded trial assessing the feasibility of comparing supportive care+amoxicillin to supportive care without antibiotics (i.e., placebo) in children 12 months to <6 years of age who present to the ED with community-acquired pneumonia (CAP) and who will be treated as outpatients. This trial will enroll over a 6-month period and take place at Ann and Robert H. Lurie Children's Hospital of Chicago. Clinical research coordinators (CRCs) will screen for and enroll eligible children. Through an online system, participants will be randomized to a 7-day course of either amoxicillin (80-100 mg/kg divided BID up to 4,000 mg/day) or matching placebo. All patients will receive a supportive care treatment bundle that includes antipyretics, honey, and saline spray, in addition to instructions on how to manage lower respiratory infections. The guardians of participants will be asked to complete an online daily symptom diary during the first 6 days after the initial study visit. Participants will have daily telehealth evaluations by clinicians for the first three days after the index study visit. The primary outcome will be assessed at day 7, using telehealth technology. A final follow-up, performed by site research staff, by telephone call, will occur at Day 21 to assess overall disease course and secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pediatric Respiratory Diseases, Antibiotic Use, Community-acquired Pneumonia
Keywords
Pediatrics, Pediatric CAP, Pediatric Pneumonia, Antibiotic Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomization to receive either oral placebo or amoxicillin for a standard course (7 days)
Arm Title
Amoxicillin
Arm Type
Active Comparator
Arm Description
Randomization to receive either oral amoxicillin or placebo for a standard course (7 days)
Intervention Type
Drug
Intervention Name(s)
Supportive Care + Amoxicillin
Intervention Description
Participants will be randomized to receive oral amoxicillin for a standard course (7 days)
Intervention Type
Drug
Intervention Name(s)
Supportive Care + Placebo (no antibiotics)
Intervention Description
Participants will be randomized to receive oral placebo for a standard course (7 days)
Primary Outcome Measure Information:
Title
Enrollment Rate Per Month
Description
Total number of participants enrolled divided by the total number of active enrollment months
Time Frame
Measured at completion of pilot trial (6 months)
Secondary Outcome Measure Information:
Title
Consent Rate
Description
Number of eligible participants approached regarding trial participation who provided informed consent to participate in the trial compared with number of participants approached for participation
Time Frame
Measured at completion of pilot trial (6 months)
Title
Lost to Follow-Up at Day 7
Description
Number of enrolled participants who did not complete the Day 7 follow-up visit
Time Frame
Measured at completion of pilot trial (6 months)
Title
Lost to Follow-Up at Day 21
Description
Number of enrolled participants who did not complete the Day 21 follow-up visit
Time Frame
Measured at completion of pilot trial (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 12-71 months; and Diagnosis of CAP, defined using established criteria: Signs and symptoms of lower respiratory tract infection (LRTI), defined as any of the following: new or different cough; or new or different sputum production; or chest pain; or dyspnea/shortness of breath; or documented tachypnea; or abnormal findings consistent with LRTI on physical examination (e.g., crackles/rales, rhonchi, wheezing) and Fever, defined as tactile temperature at home or measured temperature ≥38ºC rectal, ≥37.7ºC oral, or ≥37.5ºC axillary, and Clinician diagnosis of CAP, Intention to treat as an outpatient after ED/primary care visit, and Mild disease, defined as lack of respiratory distress per adapted Pediatric Infectious Diseases Society/Infectious Diseases Society of America criteria: none of the following: dyspnea, concerning retractions per treating clinician, grunting, nasal flaring, apnea, altered mental status, SpO2<93% in room air, or respiratory rate >50 breaths per minute for ages 12-24 months or respiratory rate > 40 breaths per minute if age>24 months. Exclusion Criteria: Hospitalization within one-month preceding study visit; or Incomplete immunization status (<2 doses of Hib and pneumococcal vaccines); or Chronic complex medical conditions (chronic heart disease followed by cardiology, chronic lung disease (not including asthma), congenital airway or lung malformations, cystic fibrosis, tracheostomy tube, requiring positive-pressure ventilation, neuromuscular disorders affecting the lungs or chest wall); or Conditions that compromise the immune system (HIV with CD4 count less than 400, primary immunodeficiency, asplenia, sickle cell disease, receipt of hematopoietic stem cell or solid organ transplant, cancer on active chemotherapy, immunosuppressive agents, daily corticosteroids for more than 7 consecutive days in past 14 days); or Systemic antibiotic receipt (more than 1 dose) within the previous two weeks of CAP diagnosis; or Radiographic findings of a consolidation of a concerning size or complexity in the view of the treating clinician; or Radiographic findings of complicated pneumonia (pleural effusion larger than trace in size, empyema, [complex/septated collection] abscess, necrotic lung disease); or Pneumonia known to be due to bacterial source at the time of enrollment, as documented by blood culture or PCR if available, or another clear source of bacterial infection requiring immediate antibiotics; or Diagnosed with pneumonia in the previous month; or Provider diagnosis of aspiration pneumonia; or Severe (type 1) drug allergy to amoxicillin; or Any other condition that in the judgement of investigators or the clinical team could affect safety of the subject; or No access to a telephone or video technology for follow-up; or Current enrollment in another clinical trial of an investigational agent; or Previous enrollment in this trial; or Parent/guardian non-English or non-Spanish speaking; or Known allergy to milk and/or red dye.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Florin, MD, MSCE
Phone
312.227.6675
Email
taflorin@luriechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Lakes
Phone
312-227-2488
Email
alakes@luriechildrens.org
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Lakes
First Name & Middle Initial & Last Name & Degree
Jill Benedetti
First Name & Middle Initial & Last Name & Degree
Todd Florin, MD, MSCE

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
As this is a pilot study, a public use dataset will not be developed.

Learn more about this trial

Supportive Treatment and Antibiotics for Mild Pediatric Pneumonia

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