Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227331
Status:
COMPLETED
Last Update Posted:
2006-05-03
First Post:
2005-09-26
Brief Title:
Equivalency Of Oral Amoxicillin Vs Injectable Penicillin In Children With Severe Pneumonia
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
A Randomized Multicentre Equivalency Study Of Oral Amoxicillin Versus Injectable Penicillin In Children Aged 3 To 59 Months With Severe Pneumonia
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical trial to determine if oral amoxicillin is equivalent in efficacy to injectable penicillin the standard treatment in the treatment of WHO-defined severe pneumonia in children between the ages of 2 and 59 months
Detailed Description:
BACKGROUND Injectable penicillin is recommended treatment for WHO-defined severe pneumonia lower chest indrawing LCI Oral amoxicillin if found equally effective could reduce referral hospitalization and treatment costs We aimed to determine whether oral amoxicillin and parenteral penicillin were equivalent in the treatment of severe pneumonia in children aged 3-59 months
METHODS This multicentre randomized open label equivalency study was conducted at tertiary care centres in 8 countries Children aged 3-59 months with severe pneumonia were hospitalized for 48 hours and if improved discharged with a 5-day course of oral amoxicillin Follow-up evaluation occurred at 5 and 14 days after enrolment The primary outcome was treatment failure persistence of LCI or new danger signs at 48 hours Analyses were by intention to treat and per protocol
RESULTS 1702 children were randomized to receive either oral amoxicillin 857 or parenteral penicillin 845 for 48 hours Treatment failure was 19 in each group risk difference -04 95 CI -42 to 33 at 48 hours 22 cumulative in each group at 5 days and 25 in each group at 14 days Relapse at day 5 and 14 occurred in 451375 34 and 651330 48 of the children respectively Infancy OR 272 95 CI 195-379 very fast breathing 194 142-265 and hypoxia 195 134-282 at baseline predicted treatment failure by multivariate analysis
CONCLUSIONS Injectable penicillin and oral amoxicillin are equivalent in the treatment of severe pneumonia in developing world areas in a controlled environment Additional research is needed in a public health setting in rural and urban areas before these finding can be recommended for widespread implementation Potential benefits of oral therapy for pneumonia include a decrease in the 1 the risk of needle-borne infections 2 need for referral or hospitalization 3 administration costs and 4 costs to the family word count 294
METHODS This multicentre randomized open label equivalency study was conducted at tertiary care centres in 8 countries Children aged 3-59 months with severe pneumonia were hospitalized for 48 hours and if improved discharged with a 5-day course of oral amoxicillin Follow-up evaluation occurred at 5 and 14 days after enrolment The primary outcome was treatment failure persistence of LCI or new danger signs at 48 hours Analyses were by intention to treat and per protocol
RESULTS 1702 children were randomized to receive either oral amoxicillin 857 or parenteral penicillin 845 for 48 hours Treatment failure was 19 in each group risk difference -04 95 CI -42 to 33 at 48 hours 22 cumulative in each group at 5 days and 25 in each group at 14 days Relapse at day 5 and 14 occurred in 451375 34 and 651330 48 of the children respectively Infancy OR 272 95 CI 195-379 very fast breathing 194 142-265 and hypoxia 195 134-282 at baseline predicted treatment failure by multivariate analysis
CONCLUSIONS Injectable penicillin and oral amoxicillin are equivalent in the treatment of severe pneumonia in developing world areas in a controlled environment Additional research is needed in a public health setting in rural and urban areas before these finding can be recommended for widespread implementation Potential benefits of oral therapy for pneumonia include a decrease in the 1 the risk of needle-borne infections 2 need for referral or hospitalization 3 administration costs and 4 costs to the family word count 294
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None