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Table 1 Independent predictors of oral antibiotic failure in fast breathing WHO non-severe childhood pneumoniaa

From: Predictors of treatment failure for non-severe childhood pneumonia in developing countries – systematic literature review and expert survey – the first step towards a community focused mHealth risk-assessment tool?

Study overview

Awasthi S et al.

CATCH UP

MASCOT

Agarwal G et al.

Noorani QA et al.

Hazir T et al.

Region (country)

Asia (India)

Asia (Pakistan)

Asia (Pakistan)

Asia (India)

Asia (Pakistan)

Asia (Pakistan)

Data collection dates

2004–2006

1998–1999

1999–2001

2000–2002

2000–2001

2005–2008

Enrollment criteria

2–59 months old

2–59 months old

2–59 months of age

2–59 months of age

2–59 months of age

2–59 months of age

Study design

Cluster randomized study

Randomized multicenter equivalency study

Randomized multicenter equivalency study

Randomized multicenter equivalency study

Multicenter observational study

Randomized multicenter equivalency study

 

Intervention arm

Oral amoxicillin 31–51 mg/kg/day for 3 days

Oral amoxicillin 50 mg/kg/day for 5 days

Oral amoxicillin 45 mg/kg/day for 3 days

Oral amoxicillin 31–54 mg/kg/day for 3 days

-

Placebo for 3 days

 

Control arm (or standard of care)

Oral trimethoprim (7–11 mg/kg/day)-sulfamethoxazole for 5 days

Oral trimethoprim (8 mg/kg/day)-sulfamethoxazole for 5 days

Oral amoxicillin 45 mg/kg/day for 5 days

Oral amoxicillin 31–54 mg/kg/day for 5 days

Oral trimethoprim (8 mg/kg/day)-sulfamethoxazole for 5 days

Oral amoxicillin 45 mg/kg/day for 3 days

 

Blinding

No

Yes

Yes

Yes

-

Yes

 

Study site types

Health centers

Tertiary care and secondary-level hospitals, and health center

Tertiary care and secondary-level hospitals

Tertiary care hospitals

Health centers

Tertiary care hospitals

 

Number of sites

14

8

7

7

14

4

 

Primary outcome

Treatment failure

Equivalency

Equivalency

Equivalency

Treatment failure

Equivalency

Treatment failure definition

 

Day of assignment

Day 3 (intervention); Day 5 (control)

Days 3 to 5

Day 5

Days 3 to 5

Day 5

Day 3

 

Respiratory ratea

Yes, elevated for age (days 3–5)

Yes, +/−5 breaths/min or higher versus enrollment (days 3–5)

Yes, elevated for age (days 3–5)

Yes, elevated for age (days 3–5)

Yes, +/−5 breaths/min or higher versus enrollment (days 3–5)

No

 

Fever >38 °C and LCI

No

No

No

No

No

No

 

Fever >38 °C

Yes (days 3–5)

No

No

No

No

No

 

LCI

Yes (days 1–5)

Yes (days 3–5)

Yes (days 1–5)

Yes (days 1–5)

Yes (days 1–5)

Yes (days 1–3)

 

Convulsions

Yes (days 1–5)

Yes (days 3–5)

Not specified

Yes (days 1–5)

Not specified

Yes (days 1–3)

 

Abnormally sleepy

Yes (days 1–5)

Yes (days 3–5)

Not specified

Yes (days 1–5)

Not specified

Yes (days 1–3)

 

Inability to drink

Yes (days 1–5)

Yes (days 3–5)

Not specified

Yes (days 1–5)

Not specified

Yes (days 1–3)

 

Stridor in calm child

Yes (days 1–5)

Yes (days 3–5)

No

No

No

Yes (days 1–3)

 

Malnutrition

No

Yes (days 3–5)

No

No

No

Yes (days 1–3)

 

Cyanosis

Yes (days 1–5)

No

Yes

No

Yes

No

 

SpO2

No

No

No

Yes, <90 % (on day 3 only)

No

No

 

Antibiotic change

No

Yes (days 3–5)

Yes (days 1–5)

No

Yes (days 1–5)

No

 

Hospitalization

No

Yes (days 1–5)

No

No

No

No

 

Lost to follow-up

Yes (days 3–5)

Yes (days 3–5)

No

Yes (days 1–5)

Yes (days 5–11)

No

 

Study withdrawal

Yes (days 1–5)

No

No

Yes (days 1–5)

No

No

 

Death

Yes (days 1–14)

Yes (days 1–5)

Yes (days 1–5)

Yes (days 1–5)

Yes (days 1–5)

Yes (days 1–5)

Study participants and description

Sample sizeb

2009

1459

1953

2188

944

873

Age 2–11 months

594/2009 (29.6 %)

732/1459 (50.2 %)

1051/1953 (53.8 %)

954/2188 (43.6 %)

334/944 (35.4 %)

573/873 (65.6 %)

Age 12–59 months

1415/2009 (70.4 %)

727/1459 (49.8 %)

902/1953 (46.2 %)

1234/2188 (56.4 %)

610/944 (64.6 %)

300/873 (34.4 %)

Treatment failure rateb

234/2009 (11.6 %)

256/1459 (17.5 %)

364/1953 (22.9 %)

225/2188 (10.3 %)

110/944 (11.6 %)

68/873 (7.8 %)

Independent predictors of treatment failure OR (95 % CI)c,d

Diarrhea, 1.65 (1.24–2.19)

History of difficulty breathing, 1.61 (1.13–2.15)

Excess respiratory rate >10 breaths/min for agea, 1.4 (1.1–1.9)

Excess respiratory rate >10 breaths/min for agea, 2.89 (1.83–4.55)

Excess respiratory rate ≥15 breaths/min for agea, 2.0 (1.2–3.4)

History of difficulty breathing, 2.86 (1.29–7.23)

 

Age 12–59 months, 1.5 (1.12–1.91)

Antibiotic non-adherence, 4.5 (95 % CI 2.9–7.0)

Antibiotic non-adherence, 11.57 (7.4–18.0

Wheeze on examination, 1.7 (1.1–2.6)

Temperature >37.5 °C at enrollment, 1.99 (1.37–2.90)

 

Illness >3 days, 1.4 (1.03–1.8)

Illness ≥3 days, 1.7 (1.3–2.1)

RSV, 1.95 (1.0–3.8)

  
  

Age 2–11 months, 1.7 (1.1–2.1)

   
  

Persistent vomiting, 1.4 (1.0–2.0)

   
  1. Serious adverse event or drug reaction, and new comorbid condition were not considered in the treatment failure definitions for any of the studies. WHO: World Health Organization; LCI: lower chest wall indrawing; SpO2: peripheral oxygen saturation; OR: odds ratio; CI: confidence interval; RSV: human respiratory syncytial virus
  2. aRespiratory rate norms: <50 breaths/min for ages 2–11 months; <40 breaths/min for ages 12–59 months
  3. bIf primary outcome of trial was equivalency or no difference was found then intervention and control arm data was combined
  4. cMultivariate logistic regression modeling was performed to determine independent predictors of treatment failure in all included studies. CATCHUP trial modeled age, history of difficulty breathing, duration of illness, and respiratory rate. The models were not reported for the MASCOT trial, Agarwal G et al., Noorani QA et al., Awasthi S et al., and Hazir T et al
  5. dFor Hazir T et al. multivariate logistic regression modeling was performed on cumulative treatment failure data from day 5 although primary outcome data was analyzed from day 3 treatment failure data
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BMC Pediatrics

ISSN: 1471-2431

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