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Poor efficacy of preemptive amoxicillin clavulanate for preventing secondary infection from Bothrops snakebites in the Brazilian Amazon: A randomized controlled clinical trial.

Abstract Secondary bacterial infections from snakebites contribute to the high complication rates that can lead to permanent function loss and disabilities. Although common in endemic areas, routine empirical prophylactic use of antibiotics aiming to prevent secondary infection lacks a clearly defined policy. The aim of this work was to estimate the efficacy of amoxicillin clavulanate for reducing the secondary infection incidence in patients bitten by Bothrops snakes, and, secondarily, identify risk factors for secondary infections from snakebites in the Western Brazilian Amazon.
PMID
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Failure of chloramphenicol prophylaxis to reduce the frequency of abscess formation as a complication of envenoming by Bothrops snakes in Brazil: a double-blind randomized controlled trial.

Authors

Mayor MeshTerms

Bothrops

Keywords
Journal Title plos neglected tropical diseases
Publication Year Start




PMID- 28692641
OWN - NLM
STAT- MEDLINE
DA  - 20170710
DCOM- 20170801
LR  - 20170801
IS  - 1935-2735 (Electronic)
IS  - 1935-2727 (Linking)
VI  - 11
IP  - 7
DP  - 2017 Jul
TI  - Poor efficacy of preemptive amoxicillin clavulanate for preventing secondary
      infection from Bothrops snakebites in the Brazilian Amazon: A randomized
      controlled clinical trial.
PG  - e0005745
LID - 10.1371/journal.pntd.0005745 [doi]
AB  - BACKGROUND: Secondary bacterial infections from snakebites contribute to the high
      complication rates that can lead to permanent function loss and disabilities.
      Although common in endemic areas, routine empirical prophylactic use of
      antibiotics aiming to prevent secondary infection lacks a clearly defined policy.
      The aim of this work was to estimate the efficacy of amoxicillin clavulanate for 
      reducing the secondary infection incidence in patients bitten by Bothrops snakes,
      and, secondarily, identify risk factors for secondary infections from snakebites 
      in the Western Brazilian Amazon. METHODS AND FINDINGS: This was an open-label,
      two-arm individually randomized superiority trial to prevent secondary infection 
      from Bothrops snakebites. The antibiotic chosen for this clinical trial was oral 
      amoxicillin clavulanate per seven days compared to no intervention. A total of
      345 patients were assessed for eligibility in the study period. From this total, 
      187 accomplished the inclusion criteria and were randomized, 93 in the
      interventional group and 94 in the untreated control group. All randomized
      participants completed the 7 days follow-up period. Enzyme immunoassay confirmed 
      Bothrops envenoming diagnosis in all participants. Primary outcome was defined as
      secondary infection (abscess and/or cellulitis) until day 7 after admission.
      Secondary infection incidence until 7 days after admission was 35.5% in the
      intervention group and 44.1% in the control group [RR = 0.80 (95%CI = 0.56 to
      1.15; p = 0.235)]. Survival analysis demonstrated that the time from patient
      admission to the onset of secondary infection was not different between
      amoxicillin clavulanate treated and control group (Log-rank = 2.23; p =
      0.789).Secondary infections incidence in 7 days of follow-up was independently
      associated to fibrinogen >400 mg/dL [AOR = 4.78 (95%CI = 2.17 to 10.55;
      p<0.001)], alanine transaminase >44 IU/L [AOR = 2.52 (95%CI = 1.06 to 5.98; p =
      0.037)], C-reactive protein >6.5 mg/L [AOR = 2.98 (95%CI = 1.40 to 6.35; p =
      0.005)], moderate pain [AOR = 24.30 (95%CI = 4.69 to 125.84; p<0.001)] and
      moderate snakebites [AOR = 2.43 (95%CI = 1.07 to 5.50; p = 0.034)].
      CONCLUSIONS/SIGNIFICANCE: Preemptive amoxicillin clavulanate was not effective
      for preventing secondary infections from Bothrops snakebites. Laboratorial
      markers, such as high fibrinogen, alanine transaminase and C-reactive protein
      levels, and severity clinical grading of snakebites, may help to accurately
      diagnose secondary infections. TRIAL REGISTRATION: Brazilian Clinical Trials
      Registry (ReBec): RBR-3h33wy; UTN Number: U1111-1169-1005.
FAU - Sachett, Jacqueline A G
AU  - Sachett JAG
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
FAU - da Silva, Iran Mendonca
AU  - da Silva IM
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
FAU - Alves, Eliane Campos
AU  - Alves EC
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
FAU - Oliveira, Samella S
AU  - Oliveira SS
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
FAU - Sampaio, Vanderson S
AU  - Sampaio VS
AUID- ORCID: http://orcid.org/0000-0001-7307-8851
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
AD  - Nucleo de Sistemas de Informacao, Fundacao de Vigilancia em Saude do Amazonas,
      Manaus, Brazil.
FAU - do Vale, Fabio Francesconi
AU  - do Vale FF
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Faculdade de Medicina, Universidade Federal do Amazonas, Manaus, Brazil.
FAU - Romero, Gustavo Adolfo Sierra
AU  - Romero GAS
AUID- ORCID: http://orcid.org/0000-0003-1425-926X
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Nucleo de Medicina Tropical, Faculdade de Medicina, Universidade de Brasilia,
      Brasilia, Brazil.
FAU - Dos Santos, Marcelo Cordeiro
AU  - Dos Santos MC
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
FAU - Marques, Hedylamar Oliveira
AU  - Marques HO
AD  - Diretoria de Ensino e Pesquisa, Fundacao Hospitalar de Hematologia e Hemoterapia 
      do Amazonas, Manaus, Brazil.
FAU - Colombini, Monica
AU  - Colombini M
AD  - Divisao de Desenvolvimento Cientifico, Instituto Butantan, Sao Paulo, Brazil.
FAU - da Silva, Ana Maria Moura
AU  - da Silva AMM
AD  - Divisao de Desenvolvimento Cientifico, Instituto Butantan, Sao Paulo, Brazil.
FAU - Wen, Fan Hui
AU  - Wen FH
AD  - Divisao de Desenvolvimento Cientifico, Instituto Butantan, Sao Paulo, Brazil.
FAU - Lacerda, Marcus V G
AU  - Lacerda MVG
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
AD  - Instituto de Pesquisas Leonidas & Maria Deane, FIOCRUZ, Manaus, Brazil.
FAU - Monteiro, Wuelton M
AU  - Monteiro WM
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
FAU - Ferreira, Luiz C L
AU  - Ferreira LCL
AUID- ORCID: http://orcid.org/0000-0002-9657-939X
AD  - Diretoria de Ensino e Pesquisa, Fundacao de Medicina Tropical Dr. Heitor Vieira
      Dourado, Manaus, Brazil.
AD  - Escola Superior de Ciencias da Saude, Universidade do Estado do Amazonas, Manaus,
      Brazil.
AD  - Faculdade de Medicina, Universidade Federal do Amazonas, Manaus, Brazil.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170710
PL  - United States
TA  - PLoS Negl Trop Dis
JT  - PLoS neglected tropical diseases
JID - 101291488
RN  - 0 (Anti-Bacterial Agents)
RN  - 804826J2HU (Amoxicillin)
RN  - 9001-32-5 (Fibrinogen)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - EC 2.6.1.2 (Alanine Transaminase)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Alanine Transaminase/blood
MH  - Amoxicillin/*administration & dosage
MH  - Animals
MH  - Anti-Bacterial Agents/*administration & dosage
MH  - Bacterial Infections/*prevention & control
MH  - *Bothrops
MH  - Brazil
MH  - C-Reactive Protein/analysis
MH  - Child
MH  - Child, Preschool
MH  - Coinfection/*prevention & control
MH  - Female
MH  - Fibrinogen/analysis
MH  - Humans
MH  - Infant
MH  - Male
MH  - Middle Aged
MH  - Pain
MH  - Regression Analysis
MH  - Snake Bites/complications/*diagnosis
MH  - Survival Analysis
MH  - Tertiary Care Centers
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2017/07/12 06:00
MHDA- 2017/08/02 06:00
CRDT- 2017/07/11 06:00
PHST- 2017/05/17 [received]
PHST- 2017/06/24 [accepted]
PHST- 2017/07/20 [revised]
AID - 10.1371/journal.pntd.0005745 [doi]
AID - PNTD-D-17-00785 [pii]
PST - epublish
SO  - PLoS Negl Trop Dis. 2017 Jul 10;11(7):e0005745. doi:
      10.1371/journal.pntd.0005745. eCollection 2017 Jul.