Citation |
Study
group |
Outcome |
Key
Results |
Study
Quality |
|
Cetinkaya
2004 |
Double-blind
randomised trial of 97 infants (2-24 months) admitted to Sisli Etfal
Education & Research Hospital, Istanbul, Turkey with severe pneumonia
treated with either benzyl penicillin & chloramphenicol or ceftriaxone intravenously for 10
days. |
The patients were
accepted as ‘cured’ when all symptoms and signs had completely
disappeared. |
Cure by 10 days in
84.7% of pen+chloro vs 80.4% of ceftriaxone group (p>0.05).
All patients
clinically well after further oral antibiotics for 1
week. |
Clear inclusion
criteria , study double-blind & good follow-up; however randomization not described,
allocation concealment unclear, power analysis not performed & no
mention of intention-to-treat. |
|
Deivanayagam
1996 |
Randomised controlled
trial of 115 children (5 months- 4yrs) admitted to Institute of Child
health and Hospital for Children, Madras, India, with pneumonia treated
with either ampicillin or
benzyl penicillin and chloramphenicol intravenously for at least 48
hours. Total duration of antibiotic therapy not
stated. |
The primary outcome
was cure rate (resolution of lung signs). Treatment failure was
considered if there was no clinical improvement with regard to fever,
tachypnoea & chest findings by 72 hours. Adverse reactions were
monitored. |
Cure rate 81% vs 90%
(p>0.05). Duration of fever
(days) 4.48 vs 4.71. Days to cure 5.64 vs
5.78. |
Clear inclusion
criteria, adequate randomization, and follow-up. Power analysis performed;
however allocation concealment unclear, no mention of blinding or
intention-to-treat. Baseline
characteristics differed with more children having cyanosis (94% vs 82%)
& nasal flare (96% vs 84%) in ampicillin
group. |
|
Duke
2002 |
Open randomised trial
of 1116 children (1 mo – 5 yrs) admitted to Goroka & Kundiawa Hospitals, PNG,
with severe pneumonia treated with either chloramphenicol or benzylpenicillin & gentamicin intramuscularly for 5
days, followed by oral antibiotics to complete 14 days
total. |
Primary outcome
measure was a good or adverse outcome. Adverse outcomes were death,
treatment failure, readmission or absconding from
hospital. Secondary outcomes
included time to resolution of hypoxaemia. |
Total primary adverse
outcome 26.3% vs 22.1% (p=0.11) Death 6% vs 5%
(p=0.35) Readmission 9% vs 6%
(p=0.03) Days oxygen sat
<90% 6.7 vs 8.0 (p=0.07) |
Clear inclusion
criteria, adequate randomisation & concealment, good follow-up, power
analysis performed & primary analysis by intention to
treat. |
|
Shann
1985 |
Single-blinded
randomised trial of 748 children (age range not mentioned) admitted to
Goroka, Kundiawa & Lae Hospitals, PNG, with severe pneumonia treated
with either chloramphenicol or
chloramphenicol & benzyl penicillin intramuscularly
(total duration not mentioned). |
Treatment defined as
failure if child died or antibiotics changed |
Mortality 13% vs 17 %
(not significant; p value not given) |
Clear inclusion
criteria, adequate randomization
& concealment; however 27% of children absconded & were
lost to follow up (majority were improving), power analysis was not
performed & no mention of intention to treat |