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Ampicillin Levels in Sputum, Serum, and Saliva

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Ampicillin Levels in Sputum, Serum, and Saliva Thorax: first published as 10.1136/thx.25.3.304 on 1 May 1970. Downloaded from Thorax (1970), 25, 304. Ampicillin levels in sputum, serum, and saliva SHEILA M. STEWART, MARY FISHER, JOY E. YOUNG, and W. LUTZ Departments of Bacteriology, Respiratory Diseases and Social Medicinte, Uniiversity of Edinburgh anid Wellcome Laboratory, City Hospital, Edinburgh The ampicillin levels in sputum, serum, and saliva from 40 patients receiving a dose of 250 mg., 26 patients receiving a dose of 500 mg., and 11 patients receiving a dose of I g. were estimated. The ampicillin was given orally four times daily. The 1-2 hour and 2-3 hour sputum levels were similar in individual patients. There was no difference in the range or mean sputum or saliva levels between specimens from patients receiving 250 mg. and 500 mg., but the levels were significantly higher after the 1 g. dose. The mean serum level sihowed a small increase after 500 mg. ampicillin as compared with the 250 mg. dose and a big increase after the 1 g. dose: only the latter difference was significant. The sputum levels were approximately 30 to 40 times lower than the corrzsponding serum levels. There was con- siderable scatter in the sputum level for any level of ampicillin in the serum: in only two of the 1-2 hour sputum specimens was there no detectable ampicillin. There was no correlation between the sputum levels and either the body weight or the dose in milligrams per kilogram. There was no evidence that corticosteroids or diuretics affected the sputum level. It was not possible to demonstrate any relationship between the purulence of the sputum and the level of ampicillin after doses of 250 mg. or 500 mg., but higher levels were found in the more purulent specimens after 1 g. doses. http://thorax.bmj.com/ Previous work (Hafez, Stewart, and Burnet, 1965) PATIENTS INVESTIGATED showed that there was considerable variation be- All patients were in hospital at the time the levels tween patients in the level of penicillin in the were investigated. The authors were not respon- sputum after intramuscular injection and that the sible for their admission, treatment or discharge. sputum levels were appreciably lower than the This sample of patients can therefore not be con- serum levels. May and Delves (1965) reported sidered a truly random sample in the statistical on September 24, 2021 by guest. Protected copyright. the serum, saliva, and sputum levels in a small sense, nor indeed is this a clinical trial with group of patients with chronic bronchitis treated patients randomly allocated to different treat- orally with ampicillin. They found considerable ments. Hence the results, and in particular the variation between patients. statistical analysis, must be interpreted with The present investigation was carried out to caution. Nevertheless since we think that the determine the range of ampicillin sputum levels in ampicillin levels reached are not strongly related a larger series of patients with respiratory disease to the criteria determining treatment, we feel the after treatment with doses of 250 mg., 500 mg. or analysis to be helpful in giving some indication 1 g. orally four times daily. Serum levels were also of possible patient response to oral ampicillin. assayed since these are the levels frequently quoted when assessing the adequacy of the dosage of a AMPICILLIN THERAPY drug. Saliva levels were estimated because con- taminatilon of sputum with saliva containing ap- 250 mg. Dose Forty patients received 250 mg. preciable quantities of th.z drug might give falsely ampicillin four times daily. Twenty-five were men high sputuum levels. Various factors which might and 15 women. Their ages ranged from 22 to affect the antibiotic levels have been analysed. 85 years with a mean age of 60-6 years. Requests for reprints: Dr. S. M. Stewart, Wellcome Labxratory, City Hospital, Greenbank Drive, Edinburgh, EH10 5SB 500 mg. Dose Twenty-six patients received 304 Thorax: first published as 10.1136/thx.25.3.304 on 1 May 1970. Downloaded from Ampicillin levels in sputum, serum, and saliva 305 500 mg. ampicillin four times daily. Twenty were METHODS men and six women. Their ages ranged from 33 to 81 years with a mean age of 61-0 years. AMPICILLIN THERAPY The dose of ampicillin was decided by the clinician in charge. All patients had I g. Dose Eleven patients received 1 g. ampicillin been receiving ampicillin for at least 18 hours before four times daily. Nine were men and two women. the assay dose. In order to ensure the exact timing Their ages ranged from 60 to 76 years, the aver- and dosage of the drug, the 6 a.m. dose on the day age being 67-3 years, significantly older than in of assay was omitted, and the last dose was given the 250 and 500 mg. dose groups. at 10 p.m. the previous evening. The assay dose was given by one of us (M. F.) at approximately 9 a.m. REPEATED ASSAYS These were carried out on 20 No antibacterial drugs other than ampicillin were the repeated assays were given. The second dose of ampicillin on the day of patients. In 15 instances assay was withheld until the last specimens for assay done on the same dose only. In three cases had been collected. repeated assays were done both on the same dose on In calculating the duration of therapy the first day and on a higher dose, and in two cases only has been considered as day 1. Only treatment with different doses (see details in Table VI). Where ampicillin in hospital has been taken into account as repeated assays were done on the same dose, only the details of other therapy were often not available. the first set of readings was used for the main analysis. MEALTIMES No attempt was made to regulate or to record the food ingested by the patients. They had CLINICAL DIAGNOSIS The clinical diagnosis on breakfast between 7.45 and 8.00 a.m. and coffee or discharge from hospital is shown in Table I. tea (sometimes with biscuits, etc.) at about 10.30 a.m. Forty-two of the patients with bronchitis had The final specimens of sputum were invariably col- exacerbations of chronic bronchitis, one had acute lected before lunch was served. bronchitis, and six had chronic bronchitis without an exacerbation. Four of the five patients with CORTICOSTEROIDS AND DIURETICS Ten of the patients asthma also had evidence of an infection. on the 250 mg. dose, six of those receiving 500 mg., and three of those on the 1 g. dose were also receiving prednisolone, 5 to 50 mg. daily. A further patient in TABLE I the 250 mg. group was given 25 units of ACTH. http://thorax.bmj.com/ CLINICAL DIAGNOSIS ON DISCHARGE IN PATIENTS INVESTIGATED and one patient in t;he 500 mg. group was given 50 mg. cortisone. both daily. Dose of Ampicillin q.i.d. Clinical Diagnosis Five patients in the 250 mg. group and four in the 250 mg. 500 mg. I g. 500 mg. group were receiving diuretics at the time Bronchitis .25 16 8 of the ampicillin assay. The diuretics were frusemide, Pneumonia .7 3 bendrofluazide or mersalyl. Bronchiectasis .3 5 2 Asthma .. .. .. .. 4 1 0 Cavitated bronchial carcinoma I1 0 0 SPECIMENS FOR ASSAY All specimens were collected Pulmonary infarction with secondary infection .. 0 1 0 by the person administering the ampicillin and deli- on September 24, 2021 by guest. Protected copyright. vered to the laboratory within two hours of collec- Total No. of patients .. .. 40 26 11 tion. Sputum was collected during the first hour after EXCLUSIONS Fourteen further patients were administration of the drug and discarded. All the examined but were excluded from the main sputum produced between the first and second hour analysis. Twelve of these patients (4 in the 250 mg. and between the second and third hour was collected for assay. In order to reduce as far as possible the mg. group, and 6 in the 1 g. group, 2 in the 500 risk of contamination of sputum specimens with group) were excluded because the antibiotic level saliva, patients were told to collect only material in the saliva was the same as or higher than the actually coughed up. At the end of each period of sputum level. In these cases an apparent sputum collection, the patient was asked to cough forcibly antibiotic level could have been due to contamina- in order to empty the bronchial passages as far as tion of the sputum with antibiotic-containing possible. saliva. These 12 cases were included in the analysis Saliva and serum were collected two hours after of the saliva levels. The remaining two cases were administration of the drug. excluded from all analyses because they had The degree of purulence of the sputum was esti- clinical renal insufficiency that might have affected mated by naked-eye examination in the laboratory. It the drug levels (Hoffler, Stegemann, and Scheler, was graded as follows: mucoid; less than 30% pus: 1966). 30 to 70% pus; more than 70% pus. Thorax: first published as 10.1136/thx.25.3.304 on 1 May 1970. Downloaded from 306 Sheila M. Stewart, Mary Fisher, Joy E. Young, and W. Lutz BACTERIOLOGICAL METHODS Penicillinase-producing Organism A series of ampi- cillin solutions in sputum containing no other inhi- Assays A cup diffusion technique, similar to that biting substances were prepared in I ml. quantities -recommended by Heathcote and Nassau (1951), was in duplicate. To one series was added one drop of an used for the ampicillin assay. A peptone yeast extract 18 hours nutrient broth culture of a strain of agar was melted and cooled to 50° C.
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