Academic journal article Bulletin of the World Health Organization

Randomized Controlled Trial of Standard versus Double Dose Cotrimoxazole for Childhood Pneumonia in Pakistan/Essai Controle Randomise Comparant L'efficacite D'une Dose Standard et D'une Double Dose De Cotrimoxazole Dans le Traitement Des Pneumopathies Infantiles Au Pakistan/Ensayo Controlado Aleatorizado De Comparacion De la Dosis Estandar Y la Dosis Doble De

Academic journal article Bulletin of the World Health Organization

Randomized Controlled Trial of Standard versus Double Dose Cotrimoxazole for Childhood Pneumonia in Pakistan/Essai Controle Randomise Comparant L'efficacite D'une Dose Standard et D'une Double Dose De Cotrimoxazole Dans le Traitement Des Pneumopathies Infantiles Au Pakistan/Ensayo Controlado Aleatorizado De Comparacion De la Dosis Estandar Y la Dosis Doble De

Article excerpt

Voir page 17 le resume en francais. En la pagina 18 figura un resumen en espanol.

Introduction

WHO estimates that 1.9 million deaths occur every year from lower respiratory infections, primarily pneumonia, mostly in developing countries (1). Because Streptococcus pneumoniae and Haemophilus influenzae are the most common causes of childhood bacterial pneumonia in developing countries, WHO, using standardized case management guidelines, recommends using oral cotrimoxazole or amoxicillin to treat non-severe pneumonia at first-level health facilities (2, 3).

Pneumonia is a leading cause of death among children in Pakistan. In 1989, the Government of Pakistan adopted WHO's recommendation to use oral cotrimoxazole as first-line outpatient treatment for non-severe pneumonia because of its cost, twice-daily dosage schedule, efficacy and wide availability (4). While high rates of resistance in nasopharyngeal and blood isolates were documented from 1986 to 1994 (5-8), studies in the early 1990s showed that cotrimoxazole was effective in treating more than 90% of children who had community-acquired pneumonia (9, 10). A 1991-92 hospital-based study found no difference in clinical efficacy between twice-daily cotrimoxazole and thrice-daily amoxicillin for treating non-severe pneumonia (failure rates of 13% and 12%, respectively) (11).

Changing from cotrimoxazole to amoxicillin would cost an estimated US$ 25 million yearly in Pakistan, a significant proportion of the national health budget (12). Due to the faster elimination of one component of cotrimoxazole (trimethoprim) in young children, higher doses are needed to achieve plasma concentrations comparable to those observed in adults, leading to the suggestion that the daily dose of trimethoprim should be increased by 100% for younger children (13). We evaluated the clinical effectiveness of cotrimoxazole in standard versus double doses to treat children with non-severe pneumonia.

Methods

Patients

We conducted a randomized controlled double-blind multi-centre trial in seven urban and two rural sites, one with dispersed health centres (Table 1). Children were seen in hospital outpatient or community clinics. Free and informed consent was obtained from children's parents; procedures followed for obtaining consent were in accordance with the ethical standards of the Declaration of Helsinki (14). The National ARI Control Programme in Pakistan approved the study.

Children aged 2-59 months presenting with cough and difficult or fast breathing (tachypnoea) were assessed using the standard WHO acute respiratory infection (ARI) algorithm, which has been shown to have a sensitivity and specificity of 80% for the diagnosis of pneumonia (2, 3). Children were classified as having non-severe pneumonia if their respiratory rate was [greater than or equal to] 50 breaths per minute and they were aged 2-11 months and if their respiratory rate was [greater than or equal to] 40 breaths per minute if they were aged 12-59 months. Children were classified as having severe pneumonia if they had lower chest wall indrawing (with or without tachypnoea); they were classified as having very severe disease if one or more danger signs were present (convulsions, drowsiness, inability to drink, stridor in a calm child, and clinically severe malnutrition).

The respiratory rate used for assessment was the average of two readings taken for 1 minute each when the child was quiet, feeding or asleep. Children who were wheezing received nebulized or inhaled salbutamol and were reassessed for tachypnoea after 30 minutes. Febrile children received paracetamol.

Children with non-severe pneumonia constituted our study population. Excluded were children with severe pneumonia, very severe disease, stridor, acute nonpulmonary or underlying chronic illness (including asthma, which was defined as a history of wheezing [greater than or equal to] 3 times if wheezing was present at the current evaluation), history of cotrimoxazole allergy, administration of WHO-recommended antimicrobials in appropriate doses during the previous 48 hours, or if the parents declined to participate. …

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