Short vs Standard Antibiotics for Childhood Pneumonia

Overseen By Khaled AL zubaidi, MD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Medical College of Wisconsin

Disqualifiers: Hemodynamic instability, Respiratory support, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 5-14 days

236 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 5-day antibiotic course is as effective as the usual 7-14 day course for treating community-acquired pneumonia in children. It also seeks to determine if a shorter course results in fewer side effects. Children hospitalized with uncomplicated pneumonia who stabilize within 72 hours of their first antibiotic dose may qualify. Participants will be randomly assigned to either the 5-day treatment or the standard treatment chosen by their doctor. The trial will compare the two groups to assess the effectiveness of the shorter treatment. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on comparing different durations of antibiotic treatment for pneumonia in children.

What is the safety track record for these treatments?

Research has shown that a shorter course of antibiotics, such as a 5-day treatment for pneumonia in children, is often as effective as longer treatments. One study found that children aged 2 to 59 months fared just as well with a shorter course compared to a longer one. Another study even found that 5 days of antibiotics worked better than 10 days for kids with uncomplicated pneumonia.

Short courses not only prove effective but might also cause fewer side effects. In a study where children didn't need hospitalization, short-course therapy offered more benefits than risks. This suggests that shorter antibiotic treatments could reduce the chance of side effects often linked with longer use, such as stomach upset or diarrhea.

Overall, the evidence is promising that shorter antibiotic treatments are safe and effective for children with community-acquired pneumonia. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores whether a shorter course of antibiotics can effectively treat childhood pneumonia compared to the standard, longer duration. Most treatments for pneumonia involve a lengthy antibiotic regimen, which can lead to side effects and antibiotic resistance. This trial's focus on a 5-day course aims to maintain effectiveness while minimizing these issues. If successful, it could lead to a shift in how we treat pneumonia, making recovery quicker and reducing the risk of antibiotic overuse.

What evidence suggests that this trial's treatments could be effective for childhood pneumonia?

This trial will compare a short course of antibiotics with the standard duration for treating childhood pneumonia. Research has shown that shorter courses can be as effective as longer ones. For instance, studies found that a 5-day course of amoxicillin achieved an 89% cure rate, nearly matching the 91% cure rate of a 10-day course. Additionally, a shorter course of amoxicillin-clavulanate proved effective for children aged 2 to 59 months with pneumonia. Similarly, a 5-day treatment with levofloxacin was as effective as longer treatments. Shorter treatments may also cause fewer side effects and reduce the risk of antibiotic resistance. This evidence suggests that a 5-day antibiotic course could be as effective as a longer one for treating pneumonia in children. ^{1 2 6 7 8}

Who Is on the Research Team?

Michelle Mitchell

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for hospitalized children aged 3 months to 18 years with uncomplicated community-acquired pneumonia. They must not have taken antibiotics before hospitalization and should be able to take oral medication or receive injections.

Inclusion Criteria

I stabilized within 3 days after starting antibiotics, without needing extra oxygen and no fever.

My scans show signs of pneumonia.

I have been diagnosed with a simple case of pneumonia caught outside of a hospital.

Exclusion Criteria

Non-English speakers

Inability to adhere to follow up

I needed help with breathing for more than 72 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 5-day or standard duration antibiotic course for community-acquired pneumonia

5-14 days

Follow-up

Participants' parents/guardians receive a follow-up questionnaire on days 5 and 14 to assess clinical improvement and side effects

14 days

2 contacts (phone/email)

What Are the Treatments Tested in This Trial?

Interventions

• Amoxicillin
• Amoxicillin-clavulanate
• Ampicillin for Injection
• Ampicillin / Sulbactam Injection
• Cefprozil
• Ceftriaxone for Injection
• Clindamycin
• Levofloxacin

Trial Overview

The study tests if a shorter, 5-day antibiotic treatment is as effective as the standard longer course (7-14 days) in treating pneumonia in children. Participants are randomly assigned to one of the two durations and followed up through questionnaires on days 5 and 14.

How Is the Trial Designed?

Group I: Short course antibiotic duration Experimental Treatment 8 Interventions

The participants in this group will receive a total antibiotic course of 5 days including the number of days received during their hospital admission and following hospital admission combined.

Group II: Standard of care antibiotic duration Active Control 8 Interventions

Participants will receive the standard-of-care antibiotic course in this group. That is, the duration of antibiotics will be decided by the primary treating physician in this group. The antibiotic course will include the number of days received during the participant's hospital admission and following hospital admission combined.

Amoxicillin is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Amoxicillin for:

• Bacterial infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Ear, nose and throat infections

Approved in United States as Amoxicillin for:

• Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract

Approved in Canada as Amoxicillin for:

• Bacterial infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Amoxicillin, introduced in 1974, is more effective than ampicillin for treating infections due to its ability to maintain higher and longer-lasting serum concentrations, making it a preferred choice for various bacterial infections.

The combination of amoxicillin with clavulanate (Augmentin) has proven particularly effective for treating pediatric infections like acute otitis media (AOM), with a high-dose formulation introduced in 2001 to better address the needs of pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amoxicillin/clavulanate for infections in infants and children: past, present and future. Klein, JO.[2019]

Sultamicillin, a prodrug combining ampicillin and sulbactam, showed no safety concerns in a study of 144 subjects, indicating it is safe for treating acute otitis media.

The clinical efficacy of sultamicillin was similar to that of amoxicillin-clavulanate, with no significant differences in effusion clearance at 10 or 30 days, suggesting it could be a viable alternative treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of sultamicillin and amoxicillin-clavulanate: treatment of acute otitis media. Chan, KH., Bluestone, CD., Tan, LS., et al.[2019]

Ampicillin/sulbactam is highly effective against a range of pediatric infections, including respiratory, urinary, skin, and bone infections, and has shown continued effectiveness against common pathogens despite resistance issues.

Sultamicillin, the oral form of ampicillin/sulbactam, has excellent tolerability and low treatment discontinuation rates, making it a preferred choice for managing pediatric infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of ampicillin/sulbactam and sultamicillin in pediatric infections: a re-evaluation. Dajani, A.[2017]

In a study of 100 children with bacterial pneumonia, those treated with amoxycillin plus clavulanic acid showed significantly better improvement in symptoms like chest pain and fever by Day 3 compared to those treated with amoxycillin alone.

The combination treatment had a higher overall clinical efficacy rate of 93.8%, compared to 60.4% for amoxycillin alone, with only two mild adverse reactions reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open, comparative evaluation of amoxycillin and amoxycillin plus clavulanic acid ('Augmentin') in the treatment of bacterial pneumonia in children. Jibril, HB., Ifere, OA., Odumah, DU.[2019]

Amoxicillin/clavulanic acid (Augmentin) is effective against common pathogens causing acute otitis media (AOM) in children, including penicillin-resistant strains, and has shown similar or better clinical response rates compared to other antibiotics in randomized trials involving pediatric patients aged 1 to 6 years.

The high-dose formulation of amoxicillin/clavulanic acid is well tolerated with a low incidence of adverse events (3.6%), making it a suitable treatment option for recurrent or persistent AOM, especially when resistant bacteria are suspected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amoxicillin/clavulanic acid: a review of its use in the management of paediatric patients with acute otitis media. Easton, J., Noble, S., Perry, CM.[2018]

In a study of 200 children with mild to severe pyodermas, amoxicillin plus clavulanic acid showed a high clinical cure rate of 96% in severe cases, outperforming other antibiotics like co-trimoxazole, which had a cure rate of only 52%.

Amoxicillin combined with clavulanic acid was well tolerated, with only mild diarrhea reported in 4% of cases, indicating a favorable safety profile for this treatment in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combination of amoxicillin and clavulanic acid in the treatment of pyoderma in children. Kar, PK.[2010]

In a study of 71 hospitalized pediatric patients aged 1 month to 16 years, intravenous and sequential intravenous-oral clavulanate-potentiated amoxycillin therapy was found to be effective, leading to clinical cure in all patients with various bacterial infections.

The treatment was generally safe, with only mild adverse effects reported, including phlebitis (6%), gastrointestinal issues (6%), and rash (4%), indicating that amoxycillin/clavulanate is a reliable option for treating serious bacterial infections in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential intravenous-oral amoxycillin/clavulanate (Augmentin) therapy in paediatric hospital practice. Schaad, UB., Pfenninger, J., Wedgewood-Krucko, J.[2019]

Increasing the pediatric amoxicillin dose from 45 mg/kg to 90 mg/kg while keeping clavulanate at 6.4 mg/kg/day significantly improved the efficacy of amoxicillin-clavulanate against penicillin-resistant strains of Streptococcus pneumoniae in a rat pneumonia model.

The higher dose effectively reduced bacterial counts for strains with lower amoxicillin minimum inhibitory concentrations (MICs of 2 and 4 microg/ml), while the lower dose was only effective against the strain with an MIC of 2 microg/ml, indicating that higher doses can enhance treatment outcomes against resistant bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of high-dose amoxicillin-clavulanate against experimental respiratory tract infections caused by strains of Streptococcus pneumoniae. Woodnutt, G., Berry, V.[2020]

Amoxicillin/clavulanate 2000/125 mg, designed to maintain effective drug levels over a 12-hour period, showed a high clinical success rate of 94.4% against penicillin-resistant Streptococcus pneumoniae (PRSP) in patients with respiratory infections, based on data from 10 clinical studies involving over 6,400 participants.

The treatment was particularly effective against PRSP strains with elevated amoxicillin MICs (4-8 mg/L), achieving a success rate of 96.2% in patients with these resistant strains, demonstrating its efficacy in overcoming antibiotic resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance in practice: bacteriological efficacy in patients with drug-resistant S. pneumoniae. Garau, J.[2019]

In a study involving 31 patients undergoing elective laparoscopy, both ampicillin with sulbactam and amoxicillin with clavulanic acid were administered intravenously, achieving effective antimicrobial concentrations in serum and peritoneal fluid within 2 hours.

The concentrations of these antibiotics reached levels that are known to be effective against bacteria in laboratory settings, suggesting their potential efficacy in preventing infections during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Penetration of sulbactam-ampicillin and clavulanic acid-amoxicillin into the pelvic peritoneum. Houang, ET., Colley, N., Chapman, M.[2021]

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