Long-Term Administration of Aerosolized Pentamidine as Primary Prophylaxis against Pneumocystis carinii Pneumonia in Infants and Children with Symptomatic Human Immunodeficiency Virus Infection

Abstract

We assessed the long-term feasibility, safety, and tolerability of two regimens of aerosolized pentamidine (AP) as primary prophylaxis of Pneumocystis carinii pneumonia (PCP) in a large sample of infants and children with symptomatic HIV infection in 21 pediatric departments. One hundred forty children were assigned to receive 60 mg every 2 weeks (n = 60) or 120 mg every 4 weeks (n = 80) of AP, delivered by the ultrasonic nebulizer Fisoneb under the supervision of trained personnel. Children underwent monthly clinical and laboratory controls for toxicity and/or development of PCP for an 18-month period. Baseline characteristics were similar in the two treatment groups. The median age was 5 years. The feasibility of administering AP was excellent in 84 (60 percent) and good in 38 (27 percent) children. All children aged <2 years showed excellent or good feasibility. Long-term compliance was good with both regimens. No child had severe adverse reactions requiring discontinuation of the treatment. Cough, sneezing, and bronchospasm were the most frequent side effects occurring, respectively, in 12, 3.7, and 0.7 percent of the 60-mg treatments and in 19.1, 6. 1, and 2.8 percent of 120-mg treatments (p < 0.05). Their incidence was not different in children younger or older than 5 years. Two episodes of PCP were observed in the group receiving 120 mg monthly, whereas none of the 60 children in the biweekly schedule had PCP (p = 0.20). AP can be safely administered to very young children with few adverse side effects.

Prophylactic Effect of FK463, a Novel Antifungal Lipopeptide, against Pneumocystis carinii Infection in Mice

“…In summary, pentamidine used as a drug control in this study is now widely used in aerosolized form for primary prophylaxis of PCP, and although its effectiveness is excellent, adverse effects, i.e., bronchospasm, dyspnea, cough, and nausea, are observed in treated patients (17,19 a DNA samples from 10 of 12 mice in the group treated with saline were subjected to PCR.…”

Analysis of Infectious Complications in Infants With Acute Lymphoblastic Leukemia Treated on the Children's Cancer Group Protocol 1953

“…There is a lack of adequate guidelines for the use of aerosolized pentamidine in children less than 5 years of age, and few trials that include this population. [36][37][38][39][40][41] It is not known if dosage adjustments are necessary or detrimental in these young children. Even less is known about intravenous pentamidine in this population.…”

Fatal bilateral pneumothoraces following administration of aerosolised pentamidine

“…16,23 A trial assessing effects of AP on infants and children also noted sneezing and headache. 28 The incidence rate of pneumothorax amongst patients who have received AP has been quoted as 4% per year and considered similar to the rate amongst historical controls. 23 Although the mechanism is not fully understood, risk factors for spontaneous pneumothorax in patients with HIV appear to include AP therapy, 29e31 smoking, 29,30,32 cysts seen on chest imaging, 29,30 and past or current infection with PCP.…”