Trial · NCT01399723
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
NCT01399723, Phase 3, Completed, KEMRI-Wellcome Trust Collaborative Research Program; results first posted 2015-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia. Trials, record NCT01399723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01399723
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
- NCT number
- NCT01399723
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 561 participants, actual
- Lead sponsor
- KEMRI-Wellcome Trust Collaborative Research Program
- Conditions
- Pneumonia
- Interventions
- Amoxicillin, Benzyl penicillin
- First posted
- 2011-07-22
- Last updated
- 2015-02-13
- Results first posted
- 2015-02-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Failure at 48 Hours (Two Full Days After Enrollment) | 48 hours | Development of any signs of very severe pneumonia at any time Hypoxemia defined as SpO2 \<85% or \<80% for altitude \< or ≥1500m respectively measured after minimum of 3 minutes on ambient air Persistent vomiting (occurring within 30 minutes of administration of amoxicillin with failure to retain drug after 3 successive attempts at administration) at any time Clinical diagnosis of new bacterial co-morbid condition requiring revision of antibiotic treatment at any time Lower chest wall indrawing Temperature ≥38◦C Respiratory rate ≥5bpm of admission rate if above age-adjusted normal upper limit |
| Secondary | Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First) | Patients will be followed up from the day of hospitalisation (day 0) until the day of medical discharge (average duration of 3 days) or until day 5 of hospitalisation (whichever occurs first). | Treatment failure as defined in the primary outcome measure. |
| Secondary | Readmission With Diagnosis of Severe or Very Severe Pneumonia Within 14 Days of Enrollment | Day 0 to Day 14 | |
| Secondary | Death at or Before Five Days Following Enrollment | Day 0 to Day 5 | Death defined as: in-hospital death occurring at any time after randomisation (recruitment for HIV-exposed participants) or verbal report of death of the enrolled patient from parent/guardian communicated either directly or via telephone conversation. |
| Secondary | Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview | Day 14 | Definition of death as described in third secondary outcome measure. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Failure at 48 Hours (Two Full Days After Enrollment) | 48 hours | Intention to treat analysis | participants | NUMBER |
| SECONDARY | Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First) | Patients will be followed up from the day of hospitalisation (day 0) until the day of medical discharge (average duration of 3 days) or until day 5 of hospitalisation (whichever occurs first). | Intention to treat analysis | participants | NUMBER |
| SECONDARY | Readmission With Diagnosis of Severe or Very Severe Pneumonia Within 14 Days of Enrollment | Day 0 to Day 14 | |||
| SECONDARY | Death at or Before Five Days Following Enrollment | Day 0 to Day 5 | |||
| SECONDARY | Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview | Day 14 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Failure at 48 Hours (Two Full Days After Enrollment) | Amoxicillin | 20 | participants | ||
| Treatment Failure at 48 Hours (Two Full Days After Enrollment) | Penicillin | 21 | participants | ||
| Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First) | Amoxicillin | 30 | participants | ||
| Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First) | Penicillin | 29 | participants | ||
| Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview | Amoxicillin | 33 | participants | ||
| Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview | Penicillin | 42 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amoxicillin 45mg/kg 12 Hourly | 263 | |
| Overall Study | STARTED | Benzyl Penicillin 50,000IU/kg 6 Hourly | 264 | |
| Overall Study | COMPLETED | Amoxicillin 45mg/kg 12 Hourly | 263 | |
| Overall Study | COMPLETED | Benzyl Penicillin 50,000IU/kg 6 Hourly | 263 | |
| Overall Study | NOT COMPLETED | Amoxicillin 45mg/kg 12 Hourly | 0 | |
| Overall Study | NOT COMPLETED | Benzyl Penicillin 50,000IU/kg 6 Hourly | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Congestive heart failure | Cardiac disorders | Amoxicillin | 1 | 263 | 1 |
| serious | Congestive heart failure | Cardiac disorders | Benzyl Penicillin | 0 | 263 | 0 |
| serious | Hypovolemic shock | Gastrointestinal disorders | Amoxicillin | 0 | 263 | 0 |
| serious | Hypovolemic shock | Gastrointestinal disorders | Benzyl Penicillin | 1 | 263 | 1 |
| serious | Renal failure | Renal and urinary disorders | Amoxicillin | 0 | 263 | 0 |
| serious | Renal failure | Renal and urinary disorders | Benzyl Penicillin | 1 | 263 | 1 |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Amoxicillin | 0 | 263 | 0 |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Benzyl Penicillin | 1 | 263 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amoxicillin | ||
| Total, all-cause mortality | Benzyl Penicillin | ||
| Total, other adverse events | Amoxicillin | 0 | 263 |
| Total, other adverse events | Benzyl Penicillin | 0 | 263 |
| Total, serious adverse events | Amoxicillin | 1 | 263 |
| Total, serious adverse events | Benzyl Penicillin | 3 | 263 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25550349 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amoxicillin vs Penicillin: Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview | Trial comparisons |
| Amoxicillin vs Penicillin: Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First) | Trial comparisons |
| Amoxicillin vs Penicillin: Treatment Failure at 48 Hours (Two Full Days After Enrollment) | Trial comparisons |
| Amoxicillin vs Benzyl Penicillin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01399723
GET https://conductscience.org/api/trials/v1/NCT01399723/registered