- Email: [email protected]
Availability of investigational drugs
Volume 98 Number 2
Editorial correspondence
A vailability of
investigational drugs
To the Editor: Johnson et al, 1 in their report "Candida peritonitis in the newborn infant," indicated that 5-fluorocytosine was given intravenously to Patient 2. We feel that readers should be made aware that this antifungal agent is available for this route of administration only from the manufacturer (Roche Labs, Nutley, N.J. 07110) due to its "investigational drug" status. Likewise, prostaglandin El, presumed to have been the analogue employed in Patient 1, is also an investigational drug (The Upjohn Co., Kalamazoo, Mich., 49001). In clinical case reports identification of investigational drugs would be most helpful to the reader. In addition, we wonder if there is a Bacillusfragilis or should the isolate have been identified as Bacteroidesfragilis?
Jeanette Wilkins, M.D. Professor of Pediatrics Richard Sakai, Pharm. D. Asst. Prof. Clin. Pharmacy University of Southern California School of Medicine Infectious Disease Laboratory 1200 North State St. Los Angeles, CA 90033 REFERENCE
1. Johnson DE, Conroy M-M, Foker JE, Ferrieri P, and Thompson TR: Candida peritonitis in the newborn infant, J PEDIATR 97:298, 1980.
Reply To the Editor:
335
better than those who did not. Bratton et al ~ reported similar results with pneumococcemia. We describe a child with meningococcemia in whom bacteremia resolved after oral treatment with amoxicillin. CASE REPORT A 4-month-old boy was referred to our Emergency Department for evaluation of fever. He had been in good health until that morning, when he became irritable. At a physician's office, his temperature had been elevated. On arrival at the hospital, his temperature was 39.6~ pulse 200/minute, and respirations 36/minute. Irritability and a full fontanelle were reported. The left tympanic membrane was inflamed. No rash was present. The hemoglobin was 10.1 gm/dl, the platelet count 551,000/ mm 3, and the white blood cell count 10,400/mm 3 with 9% bands, 57% polymorphonuclear leukocytes, 26% lymphocytes, and 8% monocytes. The spinal fluid contained 28 red blood cells and four white blood cells/mm'; the glucose concentration was 75 mg/dl, and protein 30 mg/dl. No organisms were observed on Gram stain. After a blood culture was drawn, the child was discharged with a diagnosis of otitis media, receiving amoxicillin, 50 rag/ kg/day, in three divided doses for ten days. Two days later the spinal fluid culture was negative. Neisseria meningitidis was recovered from the blood. The child returned for re-evaluation and was afebrile. The remainder of the physical examination was normal other than a dull left tympanic membrane. A blood culture was obtained which grew no organisms. The child remained well after a ten-day course of amoxicillin. COMMENT We would not recommend oral treatment in suspected meningococcemia, but the favorable outcome in this child supports the role of oral antibiotics in the initial management of children at high risk for bacteremia, but not sufficiently ill to require admission to the hospital.
Prostaglandin E1 was administered to Patient 1 on an investigational protocol through The Upjohn Co. The manufacturer (Roche) of 5-fluorocytosine, administered intravenously to Patient 2, did directly supply the agent to us, We also acknowledge the error noted by the correspondents: The organism should have been identified as Bacteroidesfragilis.
Allan D. Friedman, M.D. Division of Infectious Diseases The Joseph Stokes, Jr. Research Institute The Children "s Hospital of Philadelphia 34th and Civic Center Blvd. Philadelphia, PA 19104 Gary R. Fleisher, M.D. Assistant Professor of Pediatrics University of Pennsylvania Joseph M. Campos, Ph.D. Director, Department of Microbiology Children's Hospital of Philadelphia Stanley A. Plotkin, M.D. Professor of Pediatrics University of Pennsylvania
Dana E. Johnson, M.D. Theodore R. Thompson, M.D. Patricia Ferrieri, M.D. Department of Pediatrics Division of Neonatology and Infectious Disease D-136-4 Mayo Memorial Bldg. 420 Delaware St. S.E. Minneapolis, MN 55455 REFERENCES
Orally administered antibiotics for suspected bacteremia To the Editor: In the study of Haemophilus influenzae bacteremia by Marshall et al,' in THE JOURNAL, children receiving antibiotics orally fared
1.
2.
Marshall R, Teele DW, and Klein JO: Unsuspected bacteremia due to Haemophilus influenzae: Outcome in children not initially admitted to the hospital, J PEDIATR 95:690, 1979. Bratton L, Teele DW, and Klein JO: Outcome of unsuspected pneumococcemia in children not initially admitted to the hospital, J PEDIATR 90:703, 1977.
Editorial correspondence
A vailability of
investigational drugs
To the Editor: Johnson et al, 1 in their report "Candida peritonitis in the newborn infant," indicated that 5-fluorocytosine was given intravenously to Patient 2. We feel that readers should be made aware that this antifungal agent is available for this route of administration only from the manufacturer (Roche Labs, Nutley, N.J. 07110) due to its "investigational drug" status. Likewise, prostaglandin El, presumed to have been the analogue employed in Patient 1, is also an investigational drug (The Upjohn Co., Kalamazoo, Mich., 49001). In clinical case reports identification of investigational drugs would be most helpful to the reader. In addition, we wonder if there is a Bacillusfragilis or should the isolate have been identified as Bacteroidesfragilis?
Jeanette Wilkins, M.D. Professor of Pediatrics Richard Sakai, Pharm. D. Asst. Prof. Clin. Pharmacy University of Southern California School of Medicine Infectious Disease Laboratory 1200 North State St. Los Angeles, CA 90033 REFERENCE
1. Johnson DE, Conroy M-M, Foker JE, Ferrieri P, and Thompson TR: Candida peritonitis in the newborn infant, J PEDIATR 97:298, 1980.
Reply To the Editor:
335
better than those who did not. Bratton et al ~ reported similar results with pneumococcemia. We describe a child with meningococcemia in whom bacteremia resolved after oral treatment with amoxicillin. CASE REPORT A 4-month-old boy was referred to our Emergency Department for evaluation of fever. He had been in good health until that morning, when he became irritable. At a physician's office, his temperature had been elevated. On arrival at the hospital, his temperature was 39.6~ pulse 200/minute, and respirations 36/minute. Irritability and a full fontanelle were reported. The left tympanic membrane was inflamed. No rash was present. The hemoglobin was 10.1 gm/dl, the platelet count 551,000/ mm 3, and the white blood cell count 10,400/mm 3 with 9% bands, 57% polymorphonuclear leukocytes, 26% lymphocytes, and 8% monocytes. The spinal fluid contained 28 red blood cells and four white blood cells/mm'; the glucose concentration was 75 mg/dl, and protein 30 mg/dl. No organisms were observed on Gram stain. After a blood culture was drawn, the child was discharged with a diagnosis of otitis media, receiving amoxicillin, 50 rag/ kg/day, in three divided doses for ten days. Two days later the spinal fluid culture was negative. Neisseria meningitidis was recovered from the blood. The child returned for re-evaluation and was afebrile. The remainder of the physical examination was normal other than a dull left tympanic membrane. A blood culture was obtained which grew no organisms. The child remained well after a ten-day course of amoxicillin. COMMENT We would not recommend oral treatment in suspected meningococcemia, but the favorable outcome in this child supports the role of oral antibiotics in the initial management of children at high risk for bacteremia, but not sufficiently ill to require admission to the hospital.
Prostaglandin E1 was administered to Patient 1 on an investigational protocol through The Upjohn Co. The manufacturer (Roche) of 5-fluorocytosine, administered intravenously to Patient 2, did directly supply the agent to us, We also acknowledge the error noted by the correspondents: The organism should have been identified as Bacteroidesfragilis.
Allan D. Friedman, M.D. Division of Infectious Diseases The Joseph Stokes, Jr. Research Institute The Children "s Hospital of Philadelphia 34th and Civic Center Blvd. Philadelphia, PA 19104 Gary R. Fleisher, M.D. Assistant Professor of Pediatrics University of Pennsylvania Joseph M. Campos, Ph.D. Director, Department of Microbiology Children's Hospital of Philadelphia Stanley A. Plotkin, M.D. Professor of Pediatrics University of Pennsylvania
Dana E. Johnson, M.D. Theodore R. Thompson, M.D. Patricia Ferrieri, M.D. Department of Pediatrics Division of Neonatology and Infectious Disease D-136-4 Mayo Memorial Bldg. 420 Delaware St. S.E. Minneapolis, MN 55455 REFERENCES
Orally administered antibiotics for suspected bacteremia To the Editor: In the study of Haemophilus influenzae bacteremia by Marshall et al,' in THE JOURNAL, children receiving antibiotics orally fared
1.
2.
Marshall R, Teele DW, and Klein JO: Unsuspected bacteremia due to Haemophilus influenzae: Outcome in children not initially admitted to the hospital, J PEDIATR 95:690, 1979. Bratton L, Teele DW, and Klein JO: Outcome of unsuspected pneumococcemia in children not initially admitted to the hospital, J PEDIATR 90:703, 1977.