Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy (PRESTO-2)

Jeffrey

Status and phase: Enrolling; Phase 4

Conditions: Community-acquired Pneumonia

Treatments: Drug: Placebo; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT06125340

HHS-CB 2023-Pernica-2

Details and patient eligibility

About

Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.

Enrollment: 75 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:

  1. documented tachypnoea (>60 bpm for age <1 y, >50 bpm for 1-2 y, >40 bpm for 2-4 y, and >30 bpm for >4 y);
  2. cough on exam or by history;
  3. increased work of breathing on exam; or
  4. auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.

Exclusion criteria

• Children will be excluded if: antibiotics have been discontinued; they received >3 days of effective antibiotic treatment (excluding macrolide treatment) prior to hospitalization; there is supplemental oxygen use or fever within the past 24 h; more than 5 days elapsed since admission; the attending clinical team does not wish to use oral amoxicillin for treatment (because of allergy or any other reason); or the child is taking coumadin-based anticoagulants or tetracycline-type antibiotics (because of potential interactions with amoxicillin). Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

Short-course treatment

Experimental group

Description:

5 days of placebo (after participants already received 3-5 days of antibiotics)

Treatment:

Drug: Placebo

Standard-duration treatment

Active Comparator group

Description:

5 days of amoxicillin (after participants already received 3-5 days of antibiotics)

Treatment:

Drug: Amoxicillin