Randomised, controlled trial of effectiveness of ampicillin in mild acute respiratory infections in Indonesian children

Abstract

The recommended treatment for mild acute respiratory infections (ARI) in children is supportive care only, but many physicians, especially in developing countries, continue to prescribe antibiotic treatment because they believe it prevents progression to more severe ARI. To find out whether ampicillin treatment conferred any benefit over supportive care alone, a randomised, controlled trial was carried out among 889 children (under 5 years) with mild ARI in Indonesia. 447 were randomly allocated ampicillin (25-30 mg/kg body weight three times daily for 5 days) plus supportive care (continued breastfeeding, clearing of the nose, and paracetamol to control fever); 442 were allocated supportive care only. The treatment groups were almost identical after randomisation in terms of age, sex, level of parental education, history of measles immunisation, and fever. After 1 week the percentages cured were nearly identical (204 [46%] ampicillin; 209 [47%] control), as were the percentages of cases progressing to moderate ARI (56 [13%] vs 53 [12%]). The effect of treatment was not modified by age, sex, measles immunisation status, or the educational level of the parents. At the 2-week follow-up, the percentages cured were 62% (277) in the ampicillin group and 58% (256) in the control group; 14% of both groups had progressed to moderate ARI; and 24% (107) and 28% (123), respectively, still had mild ARI. None of the differences in outcome between the ampicillin and control groups was statistically significant. Thus, ampicillin plus supportive care offers no benefit over supportive care alone for treatment of mild ARI in young Indonesian children.

Survey of antibiotic use of individuals visiting public healthcare facilities in Indonesia

“…The results of a randomized controlled trial in West Java demonstrating that ampicillin plus supportive care offers no benefit over supportive care alone for treatment of mild respiratory tract infections in young Indonesian children, support this point. 22 Although bacterial pathogens can be found in up to 21% of acute diarrhea cases admitted to hospital, 7 most antibiotics consumed by our population were not likely to be effective. Resistance rates of enterotoxigenic Escherichia coli (ETEC) heat-labile toxin (LT) and heat-stable toxin (ST), the most frequent bacterial cause of acute diarrhea in children as well as adults in Indonesia, are 67% LT and 83% ST for ampicillin, 48% LT and 70% ST for trimethoprim-sulfamethoxazole, and 95% LT and 85% ST for tetracycline.…”

Antibiotics for the common cold and acute purulent rhinitis

“…The Herne 1980 trial was translated from French to English. One paper was excluded because a placebo was not used in the control group (Sutrisna 1991).…”

“…Excluded as not randomised. Results: showed a benefit for chloramphenicol Sutrisna 1991 Excluded as there was no placebo control group. Results: antibiotic no better than control group Townsend 1960 Excluded as used prophylactic antibiotics.…”

Community-Based Interventions for Improving Perinatal and Neonatal Health Outcomes in Developing Countries: A Review of the Evidence

“…662 conclusions. Several studies have shown that it is possible to train CHWs to recognize and successfully treat pneumonia in newborn infants in community-based settings.…”