Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02258763
• Date of registration: 23/09/2014
• Prospective Registration: Yes
• Primary sponsor: University of Malaya
• Public title: Trial on the Ideal Duration of Oral Antibiotics in Children With Pneumonia
• Scientific title: Pneumonia in Children: Aetiology, Ideal Antibiotic Duration, Quality of Life
• Date of first enrolment: November 2014
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02258763
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Malaysia

Key inclusion & exclusion criteria

Inclusion Criteria:

Children admitted with severe pneumonia as defined by the presence of all the following as
defined as below:

- 3 months to 59 months old

- History of cough and/or shortness of breath

- Unwell for <= 7 days -Increased respiratory rate ( = 50/min if =12 months old, =
40/min) or retractions,-

- Any of the following signs/symptoms are present at examination that would necessitate
admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or
lethargy

- Documented fever (axillary /central temp = 38/38.5°C) within 24 hrs of admission

- Abnormal CXR with presence of alveolar infiltrates

- Responds to IV antibiotics by the first 72 hrs and able to go home with oral
antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms

Exclusion Criteria:

Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a
doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of
bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute
illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia
e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical
suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation
(j)significant comorbidities that can increase the risk of having a complicated pneumonia-
(k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary
infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics
(o) underlying illness that can predispose to recurrent pneumonia

-



Age minimum: 3 Months
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Pneumonia

Intervention(s)

Drug: Amoxicillin-Potassium Clavulanate Combination

Drug: Placebo

Primary Outcome(s)

Clinical cure [Time Frame: 30 days]

Secondary Outcome(s)

Impact of pneumonia on the parent [Time Frame: on admission, at discharge, at follow-ups(average 1 week, 4 weeks, 6 months and 1 year)]

Bacterial isolates [Time Frame: at the 4 weeks appointment]

Quality of life of child and parent [Time Frame: on admission, at discharge, at follow-ups( 4 weeks, 6 months and 1 year)]

Time to next hospitalisation or visit to healthcare unit [Time Frame: during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year]

Prevalence of chronic respiratory symptoms and signs post pneumonia [Time Frame: during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 yea]

Severity of pneumonia [Time Frame: during the admission which expected duration will be 5 days, daily twice a day to do the questionnaires]

Adverse effects [Time Frame: at 4 weeks follow-up]

Number hospitalised for pneumonia or unscheduled healthcare visits [Time Frame: during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year]

Radiological resolution [Time Frame: at the 4 weeks appointment]

Severity of cough during 4 weeks post-discharge [Time Frame: at the 4 weeks appointment, cough diary which will be done by parents daily from discharge]

Secondary ID(s)

RP026-14HTM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Menzies School of Health Research