Trial Outcomes & Findings for Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia (NCT NCT01399723)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

561 participants

Primary outcome timeframe

48 hours

Results posted on

2015-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Amoxicillin 45mg/kg 12 Hourly Amoxicillin: Oral 45mg/kg 12 hourly	Benzyl Penicillin 50,000IU/kg 6 Hourly Benzyl penicillin: Intravenous 50,000IU/kg 6 hourly
Overall Study STARTED	263	264
Overall Study COMPLETED	263	263
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Amoxicillin 45mg/kg 12 Hourly Amoxicillin: Oral 45mg/kg 12 hourly	Benzyl Penicillin 50,000IU/kg 6 Hourly Benzyl penicillin: Intravenous 50,000IU/kg 6 hourly
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amoxicillin n=263 Participants Amoxicillin 45mg/kg 12 hourly	Penicillin n=264 Participants Benzyl penicillin 50000 IU 6 hourly	Total n=527 Participants Total of all reporting groups
Age, Continuous	14 years n=39 Participants	13 years n=41 Participants	13 years n=35 Participants
Sex: Female, Male Female	120 Participants n=39 Participants	106 Participants n=41 Participants	226 Participants n=35 Participants
Sex: Female, Male Male	143 Participants n=39 Participants	158 Participants n=41 Participants	301 Participants n=35 Participants
Region of Enrollment Kenya	263 participants n=39 Participants	264 participants n=41 Participants	527 participants n=35 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Intention to treat analysis

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

Outcome measures

Outcome measures
Measure	Penicillin n=263 Participants Benzyl penicillin 50000 IU/kg 6 hourly	Amoxicillin n=263 Participants Amoxicillin 45mg/kg 12 hourly
Treatment Failure at 48 Hours (Two Full Days After Enrollment)	21 participants	20 participants

SECONDARY outcome

Timeframe: 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).

Population: Intention to treat analysis

Treatment failure as defined in the primary outcome measure.

Outcome measures

Outcome measures
Measure	Penicillin n=263 Participants Benzyl penicillin 50000 IU/kg 6 hourly	Amoxicillin n=263 Participants Amoxicillin 45mg/kg 12 hourly
Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First)	29 participants	30 participants

SECONDARY outcome

Timeframe: Day 0 to Day 14

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 14

Definition of death as described in third secondary outcome measure.

Outcome measures

Outcome measures
Measure	Penicillin n=250 Participants Benzyl penicillin 50000 IU/kg 6 hourly	Amoxicillin n=244 Participants Amoxicillin 45mg/kg 12 hourly
Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview	42 participants	33 participants

Adverse Events

Amoxicillin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Benzyl Penicillin

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Amoxicillin n=263 participants at risk Amoxicillin 45mg/kg 12 hourly	Benzyl Penicillin n=263 participants at risk Benzyl Penicillin 50,000IU/kg 6 hourly
Cardiac disorders Congestive heart failure	0.38% 1/263 • Number of events 1	0.00% 0/263
Gastrointestinal disorders Hypovolemic shock	0.00% 0/263	0.38% 1/263 • Number of events 1
Renal and urinary disorders Renal failure	0.00% 0/263	0.38% 1/263 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/263	0.38% 1/263 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ambrose Agweyu

KEMRI-Wellcome Trust Research Prorgamme

Phone: 254202715160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place