Text Box:  Name, Year & Country

Study Type

Clinical Question

No Pts.

Level of Evidence

Outcomes or Results

Secondary data

Reviewers Comments & Assessment of Methodology

1. Fransen

1984

Kenya

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 1: 53 infants with GNICD were randomised to receive 75mg IM Kanamycin and either gentamicin eye ointment or N saline eye washes

Arm 2: 38 infants with GNICD were randomised to receive 150mg IM of Kanamycin with either gentamicin eye ointment or N saline eye washes

Arm 3: 26 infants with GNICD were randomised to receive 150mg of Kanamycin with either gentamicin or Chloramphenicol eye ointment

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

Kenya

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

Kenya

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

No ON prophylaxis programme

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 Africa

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

Kenya

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

No ON prophylaxis

More than 30% of women giving birth had N gonorrhoeae/ Chlamydia/ syphilis despite 99% attendance at ANC

 

 

 

 

6. Laga

1986

Kenya

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

Zimbabwe

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

No ON prophylaxis programme

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

Rwanda

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 OM

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

Rwanda

Journal of AntimicrobChemo

 

Case series

 

 

 

Is single dose Cefotaxime therapy effective treatment for N gonorrhoeae ON

Cases: Neonates and Infants presenting with culture proven Ng ON

 

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

India

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

India

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

No ON prophylaxis given to babies

12/17 babies with Chlamydia ON developed symptoms before day 4

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

Nigeria

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