|
|
Study Type |
Clinical Question |
No Pts. |
Level of Evidence |
Outcomes or Results |
Secondary data |
Reviewers
Comments & Assessment of Methodology
|
|
1. Fransen 1984 Lancet |
Randomised
non blinded Approx
85% follow up rate |
Effectiveness of variable dose IM Kanamycin
together with saline/ gentamicin ointment/ Chloramphenicol eye ointment in
treating ON Cases: Neonates presenting with ON |
117 |
2b |
Arm Arm Arm |
PPNG between 20-25% 13/117 babies with ON had Chlamydia and did not
respond to the initial treatment |
Larger
study in developing country Probably
no prophylaxis offered (though not stated) Significant
loss to followup PPNG
estimated at 20-25% No
bacteriological failures in treatment of ON due to N. gonorrhoeae in those
treated with either 75 or 150mg Kanamycin with concomitant use of gentamicin
ointment Few
treatment failures in other groups One baby
treated with 75mg Kanamycin and saline developed sepsis and corneal
ulceration No side effect reporting |
|
2. Fransen 1986 Journal of Inf Dis |
Cohort |
Describe prevalence of N gonorrhoea and Chlamydia
in neonates presenting with ON Cases: Neonates presenting with ON |
149
infants and mothers |
2b |
64(43%) of babies had N gonorrhoea (23% of these
PPNG) 20 (13%) had Chlamydia 6 (4%) had both Overall N gonorrhoeae/ Chlamydia accounted for 60%
of all presentations |
23% of N gonorrhoea isolates PPNG Extraoccular infection with N gonorrhoeae and
Chlamydia documented in 17% and 37% of cases |
Large cohort set in developing country None received prophylaxis but some had received
pre treatment with AB Some of data previously reported (117 patients) Documented one treatment failure with an infant
treated with Kanamycin (? Dose) and topical gentamicin: developed corneal
ulcers and disseminated N gonorrhoea. 6 infants with mixed infection developed post
gonococcal conjunctivitis 3 to 10 days after treatment for N gonorrhoeae |
|
3. Haase 1986 Sex Transm Dis |
Case series |
Is single dose Ceftriaxone an effective
treatment for ON? Cases: Neonates presenting with purulent ON and GNICD |
7 |
4 |
Of 7
neonates, 5 were eye culture positive for N. Gonorrhoeae alone, one positive
for Chlamydia alone and one positive for both. All infants were treated with
125mg of IM Ceftriaxone. Those with Chlamydia were also treated with
Erythromycin 20mg/ kg bd for 14 days. One infant was lost to final follow up
(N. gonorrhoeae only). The 2 infants with Chlamydia showed improvement but
not cure. The 4 remaining infants with N. gonorrhoeae showed cure at follow
up |
PPNG 4/6 66.6% No Chlamydia/N g rate data |
Very
small observational study Neonates
less than 4 weeks presenting with purulent eye discharge with eye swabs
showing gram neg ICD Treated
and then followed at day 1,3,7 and 10 Clinical
and microbiological cure demonstrated with Neisseria Study set
in a developing country No side
effects recorded (no description of tolerance of large dose erythromycin) 4 of 6
isolates were Penicillinase producing |
|
4. Hoosen 2002 South African Med Journal |
Case series |
Effectiveness of low dose (62.5mg)
Ceftriaxone treatment for ON Cases: Neonates presenting with ON And culture pos Ng |
21 |
4 |
All 21 babies positive for N g demonstrated microbiological cure on swabs taken
24h post treatment 7 infants with concurrent Chlamydia received
Erythromycin approx 20mg/kg QID for 7/7 |
PPNG 10% |
Small study No prophylaxis data No side effect data Chlamydia screened for and treated with
Erythromycin |
|
5. Laga 1986 Lancet |
Cohort |
Describe prevalence of N gonorrhoeae and Chlamydia
in neonates and mothers Cases: Prospective screening of mothers and
infants |
1013
mothers and 1019 babies (6 twins) |
2b |
Prevalence of N gonorrhoeae and Chlamydia in
birthing mothers was 7 and 29% resp. Identified 181 cases of ON: 31% due to Chlamydia,
12% due to N gonorrhoeae and 3% due to both Transmission rates from mother to child’s eye were
42% and 31% resp. for N gonorrhoeae and Chlamydia Rates for transmission to throat were 7 and 2%: |
52.4% PPNG |
Large prospective cohort study set in developing
country More than 30% of women giving birth had N
gonorrhoeae/ Chlamydia/ syphilis despite 99% attendance at ANC |
|
6. Laga 1986 NEJM |
Randomised non-blinded |
Compare treatment of N gonorrhoeae ON with
Ceftriaxone, Kanamycin and topical gentamicin and Kanamycin and topical
tetracycline Cases: Neonates presenting with purulent ON and Gm
neg ICDC on gram stain |
122 |
1b |
105/122 patients returned for follow up 3 of 61 infants treated with Kanamycin had
persistent or recurrent N gonorrhoeae compared to no of 61 receiving
Ceftriaxone |
28*% PPNG 14.8% concomitant Chlamydia infection |
Randomised trial conducted in developed country No ocular prophylaxis but some patients treated
with Ab prior to enrolment 3 treatment failures with Kanamycin Poor
outcome data for Chlamydia and for extraoccular gonococcal infection |
|
7. Latif 1988 Sex Transm Dis |
Cohort |
Is single dose Kanamycin together with topical
saline irrigation an effective treatment for ON? Cases: Neonates presenting with ON And culture proven Ng |
219 |
2b |
219 neonates with culture proven N. gonorrhoeae ON
were treated with single dose Kanamycin 100mg IM and saline irrigation. 7 were lost to followup At day 3, N. gonorrhoeae was isolated from 3 babies
(1.4%) |
PPNG 40/219 18.3% 261 babies with ON of which 219 had culture
positive N g |
Larger
study set in developing country 40 babies
had Penicillinase producing strains of N. gonorrhoeae 22 of 219
infants with persistent purulent discharge at day 3 but culture negative for
N. gonorrhoeae were said to have postgonococcal conjunctivitis and treated
with oral erythromycin and tetracycline eye ointment No side
effect data reported |
|
8. Lepage 1988 British Journal Opthalmol |
Case series |
Is single dose IM Cefotaxime therapy Effective treatment for ON? Cases: Neonates presenting with ON and culture proven Ng |
9 |
4 |
100% cure rate for ON (microbiological and
clinical) with single dose of 100mg/kg of Ceftriaxone without topical eye
treatment |
PPNG 5/9 No N g or Chlamydia rate data |
Small
study set in developing country 9 infants
presenting with symptoms and positive culture from eye swab On child
treated with 5/7 of ceftriaxone because of concomitant No
prophylaxis data No side
effect data PPNG 5/9
in this series No
reported post gonococcal ON (presumably no concurrent Chlamydia) |
|
9. Lepage 1990 Journal of AntimicrobChemo |
Case series |
Is single dose Cefotaxime therapy
effective treatment for N gonorrhoeae ON Cases: Neonates and Infants presenting with culture
proven |
21 19 only
treated with single dose |
4 |
Combined results from earlier study n=9, 1988 12 additional patients, 3 patients older than 1
year For 9 new infant patients, treated with 100mg / kg
Ceftriaxone, clinical cure in 100% day 2-5. Microbiological cure demonstrated
in 5/5post treatment cultures obtained. |
Overall PPNG rate 57% |
Small study set in developing country. Some of
the cases previously reported by the same author. 3 older children included
in n=21 No side effect data. Some pre-treatment unlikely to significantly
affect clinical data. No prophylaxis data Post treatment culture only in 5/9 new infant
cases No post gonococcal ON identified (concomitant
Chlamydia) |
|
10. Mani 1996 Journal of Indian Med Ass |
Case series |
Spectrum of organisms responsible for ON in
hospital born babies Cases: Neonates presenting with ON |
30 |
4 |
Predominance of pseudomonas with no Ng and only 2
possible Chlamydia infections |
|
No prophylaxis data. Pseudomonas seems to be nosocomially acquired Not all patients were assessed for Chlamydia
infection |
|
11. Mohile 2002 Indian Journal of Opthalmol |
Case series |
Report prevalence of organisms responsible for ON Cases: Neonates presenting with ON |
70 |
4 |
Chlamydia accounted for 24% (17/70) of babies
presenting with ON Other organisms, staph epi, staph A, no Neisseria g |
6/17 recurrence of conjunctivitis at 14 weeks with
oral erythromycin 40-50mg/kg/day for 14 days |
Larger case series in developing country 12/17 babies with Not clear whether recurrence of Chlamydia
conjunctivitis was due to primary treatment failure (poor compliance/
ineffective treatment) or reinfection. No baby clinically developed Chlamydia pneumonia |
|
12. Olatunji 2004 West African Journal of Medicine |
Case control study |
Describe causative agents and their Ab sensitivity
in ON Cases: neonates presenting with ON |
200 cases
200 controls |
3b |
200 cases with ON were matched with 200 controls
without clinical ON Of 200 cases with ON 111 had organisms isolated 9/111 cases had Chlamydia 1/111 cases had N g 85/111 cases isolated Staph A: 86% sensitive to
cefotaxime, 78% sensitive to Kanamycin Of the controls 79/200 had positive isolates 3/ 200 had subclinical Chlamydia 50/400 reported a variety of pre-presentation
treatments |
Only one case of N g/ 200 9/200 with ON had Chlamydia proven |
Large
study but mainly descriptive All
babies with ON were treated with erythromycin and topical tetracycline No
outcome data It is not clear whether the asymptomatic controls
were also treated with ab when isolates were positive Chlamydia testing was only performed at 3/6
settings because of poor tolerance to conjunctival scraping (not clear how
many were seen at each setting Only 134/400 came to follow up AB sensitivity for N g and Chlamydia not reported |