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Otitis Media of Infancy and Early Childhood: Title and subTitle BreakA Double-Blind Study of Four Treatment Regimens FREE

Lula Hinton Jackson; Joan Clahsen, RN; John D. Nelson, MD; Jorge E. Howard, MD
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Accepted for publication May 3, 1976.

Reprint requests to 5323 Harry Hines Blvd, Dallas, TX 75235 (Dr Nelson) (available only to persons outside the United States).


Arch Pediatr Adolesc Med. 1976;130(9):965-970. doi:10.1001/archpedi.1976.02120100055008
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• A double-blind, randomized trial of four antimicrobial regimens was conducted in 383 infants and children with acute otitis media. The drugs used were penicillin V, amoxicillin trihydrate, erythromycin estolate, and erythromycin estolate with trisulfapyrimidines. Aspiration of middle ear fluid for culture was done before treatment and repeated during treatment if fluid persisted. Etiologic bacteria were most commonly pneumococci (31%) or Haemophilus sp (22%), and an additional 5% of patients had both organisms. Amoxicillin was the most effective in promoting initial response in pneumococcal infection. For Haemophilus infections, the cure rates with amoxicillin and the erythromycin-trisulfapyrimidines mixture were significantly better than with the other two regimens, and serous otitis did not occur during the follow-up period; however, new episodes of otitis were comparable in the four groups. Amoxicillin and the erythromycin estolate-trisulfapyrimidines combination appear to be somewhat more effective than penicillin V or erythromycin estolate.

(Am J Dis Child 130:965-970, 1976)

REFERENCES

Stickler GB, Sasano JR Jr, McBean JB:  Treatment of acute otitis media in children: A clinical trial . Clin Pediatr 2:535-540, 1963;.
Stickler GB, McBean JB:  The treatment of acute otitis media in children: II. A second clinical trial . JAMA 187:85-89, 1964;.
Sell SHW, Sanders RS:  Therapy with erythromycin estolate for otitis media associated with Haemophilus influenzae infection . Antimicrob Agents Chemother , pp 756-758, 1963;.
Rubenstein MM, McBean JB, Hedgecock LD, et al:  The treatment of acute otitis media in children: III. A third clinical trial . Am J Dis Child 109:308-313, 1965;.
Stickler GB, Rubenstein MM, McBean JB, et al:  Treatment of acute otitis media in children: IV. A fourth clinical trial . Am J Dis Child 114:123-130, 1967;.
Bass JW, Cohen SH, Corless JD, et al:  Ampicillin compared to other antimicrobials in acute otitis media . JAMA 202:697-702, 1967;.
Lenoski EF, Wingert WA, Wehrle PF:  Drug trials in acute otitis media . Curr Ther Res 10:631-639, 1968;.
Halsted C, Lepow ML, Balassanian N, et al:  Otitis media: Clinical observations, microbiology, and evaluation of therapy . Am J Dis Child 115:542-551, 1968;.
Nilson BW, Poland RL, Thompson RS, et al:  Acute otitis media: Treatment results in relation to bacterial etiology . Pediatrics 43:351-358, 1969;.
Howie VM, Ploussard JH:  The "in vivo sensitivity test": Bacteriology of middle ear exudate . Pediatrics 44:940-944, 1969;.
Laxdal DE, Merida J, Jones RHT:  Treatment of acute otitis media: A controlled study of 142 children . Can Med Assoc J 102:263-268, 1970;.
Bass JW, Cashman TM, Frostad AL, et al:  Antimicrobials in the treatment of acute otitis media: A second clinical trial . Am J Dis Child 125:397-402, 1973;.
Stickler GB:  How many more treatment trials in otitis media? Am J Dis Child 125:403, 1973;.
Sell SHW, Karzon DT (eds): Hemophilus influenzae . Nashville, Tenn, Vanderbilt University Press, 1973;.
Feigan RD, Shackelford PG, Campbell J, et al:  Assessment of the role of Staphylococcus epidermidis as a cause of otitis media . Pediatrics 52:569-576, 1973;.
Coffey JD Jr:  Otitis media in the practice of pediatrics: Bacteriological and clinical observations . Pediatrics 38:25-32, 1966;.
Kamme C:  Evaluation of the in vitro sensitivity of Neisseria catarrhalis to antibiotics with respect to acute otitis media . Scand J Infect Dis 2:117-120, 1970;.
Nelson JD, Haltalin KC:  Amoxicillin less effective than ampicillin against Shigella in vitro and in vivo: Relationship of efficacy to activity in serum . J Infect Dis 129;S222-S227, 1974;.
McCracken GH Jr: Factors affecting gastrointestinal absorption of antibiotics. Read before the 14th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, 1974.
Howie VM, Ploussard JH, Sloyer J:  The "otitis-prone" condition . Am J Dis Child 129:676-678, 1975;.

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Stickler GB, Sasano JR Jr, McBean JB:  Treatment of acute otitis media in children: A clinical trial . Clin Pediatr 2:535-540, 1963;.
Stickler GB, McBean JB:  The treatment of acute otitis media in children: II. A second clinical trial . JAMA 187:85-89, 1964;.
Sell SHW, Sanders RS:  Therapy with erythromycin estolate for otitis media associated with Haemophilus influenzae infection . Antimicrob Agents Chemother , pp 756-758, 1963;.
Rubenstein MM, McBean JB, Hedgecock LD, et al:  The treatment of acute otitis media in children: III. A third clinical trial . Am J Dis Child 109:308-313, 1965;.
Stickler GB, Rubenstein MM, McBean JB, et al:  Treatment of acute otitis media in children: IV. A fourth clinical trial . Am J Dis Child 114:123-130, 1967;.
Bass JW, Cohen SH, Corless JD, et al:  Ampicillin compared to other antimicrobials in acute otitis media . JAMA 202:697-702, 1967;.
Lenoski EF, Wingert WA, Wehrle PF:  Drug trials in acute otitis media . Curr Ther Res 10:631-639, 1968;.
Halsted C, Lepow ML, Balassanian N, et al:  Otitis media: Clinical observations, microbiology, and evaluation of therapy . Am J Dis Child 115:542-551, 1968;.
Nilson BW, Poland RL, Thompson RS, et al:  Acute otitis media: Treatment results in relation to bacterial etiology . Pediatrics 43:351-358, 1969;.
Howie VM, Ploussard JH:  The "in vivo sensitivity test": Bacteriology of middle ear exudate . Pediatrics 44:940-944, 1969;.
Laxdal DE, Merida J, Jones RHT:  Treatment of acute otitis media: A controlled study of 142 children . Can Med Assoc J 102:263-268, 1970;.
Bass JW, Cashman TM, Frostad AL, et al:  Antimicrobials in the treatment of acute otitis media: A second clinical trial . Am J Dis Child 125:397-402, 1973;.
Stickler GB:  How many more treatment trials in otitis media? Am J Dis Child 125:403, 1973;.
Sell SHW, Karzon DT (eds): Hemophilus influenzae . Nashville, Tenn, Vanderbilt University Press, 1973;.
Feigan RD, Shackelford PG, Campbell J, et al:  Assessment of the role of Staphylococcus epidermidis as a cause of otitis media . Pediatrics 52:569-576, 1973;.
Coffey JD Jr:  Otitis media in the practice of pediatrics: Bacteriological and clinical observations . Pediatrics 38:25-32, 1966;.
Kamme C:  Evaluation of the in vitro sensitivity of Neisseria catarrhalis to antibiotics with respect to acute otitis media . Scand J Infect Dis 2:117-120, 1970;.
Nelson JD, Haltalin KC:  Amoxicillin less effective than ampicillin against Shigella in vitro and in vivo: Relationship of efficacy to activity in serum . J Infect Dis 129;S222-S227, 1974;.
McCracken GH Jr: Factors affecting gastrointestinal absorption of antibiotics. Read before the 14th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, 1974.
Howie VM, Ploussard JH, Sloyer J:  The "otitis-prone" condition . Am J Dis Child 129:676-678, 1975;.

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