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Efficacy of Azithromycin versus Ceftriaxone for the treatment of uncomplicated

typhoid fever in children

Article · October 2020

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Original Article

Efficacy of Azithromycin versus Ceftriaxone for the

treatment of uncomplicated typhoid fever in children
Ishrat Jahan1, Mohammad Enamul Karim2, Md. Kamrul Ahsan Khan3, Khan
Nizamuddin4, Habiba Anjuman5, Ferdous ara6

ABSTRACT:

Introduction: Typhoid fever is a global major public health problem. Its incidence is high in
children from both low & high socio economic groups. Antimicrobial therapy is important in its
management. MDR case has begun to appear around 1990. Ciprofloxacin resistance was first
reported in Bangladesh in 2000.6 Ceftriaxone is still highly effective, but costly and requires
parental administration and cumbersome to children. So an effective, safe and alternative drug
in the treatment of typhoid fever is always a demand. Azithromycin is a potential drug in
treatment of typhoid fever because of its high intracellular penetration and long half-life (72
hours). Aims & Objectives- To determine the efficacy of Azithromycin versus Ceftriaxone in the
treatment of uncomplicated typhoid fever. Methodology- This RCT was conducted in the
Department of Paediatrics of Shaheed Mansur Ali Medical College & Hospital, Dhaka; over a
period of 6 (six) months. A total of 35 cases (Azithromycin) & 35 controls (Ceftriaxone) were
included in this study. Results- Most respondents in both groups were ≤ 5 years’ age. Mean age
was 5.53±3.41years for cases and 5.53±2.55 years for controls (p-0.146). In both groups M:F
ratio was 1:1. Mean weight was 17.30±6.13 kg for cases and 17.17± 6.55kg for control (p-
0.798). Most respondents were from middle socio-economic classes (p-0.083). Clinical
presentation was similar in both groups. A quarter of participants in each group (25.7% &
22.9%) gave history of receiving antibiotic before admission. ‘Widal test’ was negative in 2.9%
of cases and 5.7% of Control (p-0.328). S. typhi. was present in blood culture in majority cases
except, 14.3% in Azithromycin and 8.6% in Ceftriaxone group yelled ‘no growth’ (p-0.241).
Repeat blood culture on day10, showed no growth in all the 54 culture positive cases. Children
of Azithromycin group was afebrile within 6 days of starting treatment, mean 4.88± 0.40 days
and in Ceftriaxone group most (97.1%) required ≥7 days, mean 7.14±0.42 days (p-0.001). As
defervescence was achieved before the completion of treatment, both the groups were
discharged in due time, i.e. Azithromycin group after 7 days and Ceftriaxone group after 10
days. Conclusion- Treatment of uncomplicated typhoid fever with Azithromycin is relatively

1. Asst. Registrar, Uttara Adhunik Medical College and Hospital

2. Registrar, National Heart Foundation Hospital and Research Institute, Mirpur. Dhaka
3. Assistant Professor Neonatology. Sheikh Sayera Khatun Medical College. Gopalgonj.
4. Professor and Head, Department of Paediatrics, Shaheed Mansur Ali Medical College & Hospital, Dhaka
5. Asst. Registrar, Uttara Adhunik Medical College and Hospital, Dhaka.
6. Registrar, Uttara Adhunik Medical College and Hospital, Dhaka.

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P a g e 16
easier; takes shorter time to achieve defervescence and the duration of treatment is also shorter
in comparison to Ceftriaxone.
Key words: Typhoid fever, Azithromycin, Ceftriaxone.
(The Planet 2019; 3(2):16-25)

INTRODUCTION: Salmonella typhi infection with widely

variable sensitivity pattern to commonly
Typhoid fever is a systemic infection caused
first line drugs.6 MDR case begun to appear
by bacterium salmonella enterica serotype
around 1990. Ciprofloxacin & Ofloxacine
typhi. It is a common febrile illness among
resistance was first reported in Bangladesh
the children of developing country and a
in 8% of enteric fever case in year 2000. In
global major public health problem. Almost
the year 2005 a resistance pattern of 70%
80% of the cases and deaths are in Asia &
was observed.6 Fluroquinolones have
rests occur mostly in Africa.1 High incidence
proven to be effective, however to date they
of typhoid fever (>100/100000 case per
are restricted from routine use in children
year) include south central Asia and south
and quinolone resistant strain of Salmonella
East Asia, the existing estimate of the global
typhi have begun to be reported.7
burden of typhoid fever is 16 million illness
and 6 lac deaths annually.2 Its incidence is Ceftriaxone and other 3rd generation
high in children from both low & high socio cephalosporins are still highly effective
economic groups.3 If left untreated the against S. typhi, in addition to the high cost
disease carries mortality rate up to 30%.4 and requirement of parental administration,
Hence antimicrobial therapy is important in which is cumbersome and is an unpleasant
its management. Previous first line drug in experience for the children. Therefore, other
the treatment of typhoid fever were regimens are required for the treatment of
chloramphenicol, tetracycline, typhoid fever.
sulphonamide. 4
Azithromycin, a member of macrolide class
Chloramphenicol has been the treatment of of antibiotic, possesses many characteristics
choice for typhoid fever for 40 years, but for effective and convenient treatment of
wide spread emergence of multi drug typhoid fever. Including in vitro activity
resistance (MDR) salmonella typhi resistant against many enteric pathogens, it has
to Ampicillin, Chloramphenicol, excellent penetration into most tissue,
Trimethoprime, Sulphamethoxazole, has macrophage and neutrophil that are more
necessitate the search for other therapeutic than 100 fold higher than concentration in
option.5 serum.8 Previous studies have
demonstrated that a seven days treatment
In Bangladesh typhoid fever is endemic due
course of Azithromycin was highly effective
to defective sewerage system, unsafe water
against uncomplicated typhoid fever in
& food handling. Recent reports from Dhaka
adult and children.8 Azithromycin is a
and Khulna reveal higher incidence of MDR
potential useful drug in treatment of typhoid

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P a g e 17
fever because of its high intracellular Azithromycin and Group-B, were given
penetration and long elimination half life intravenous Ceftriaxone. At the end of the
(72 hours). Azithromycin significantly study group A were taken as a case & group
reduce clinical failure and duration of B as control.
hospital stay and reduce relapse.9
Inclusion criteria was children of both sexes
Azithromycin appears to be an effective
between 2-12 years, having fever for ≥7days
drug for treating uncomplicated typhoid
& ≥2 of the symptoms, abdominal pain,
fever in children with efficacy rate of more
hepatomegaly, splenomegaly or coated
than 90%.10
tongue with positive Widal test & or blood
Due to the emergence of MDR S. typhi, and culture, parents of whom has given
resistance patterns varies in different informed written consent. Children, whose
regions, this study is focused on alternative parents didn’t give written consent, who had
drugs for its treatment and also to assess the history of allergy to Ceftriaxone/
efficacy of Azithromycin for typhoid fever in Azithromycin, or children with major
children of developing country. If complication of typhoid fever like intestinal
Azythromycin is found to be effective in haemorrhage, perforation, shock etc. were
enteric fever it will be a glorious massage for excluded.
us and will be a paramount significance for
Group A, received Azithromycin 20
the clinicians to start empirical therapy in
mg/kg/day in two divided oral doses for 7
hospital as well as in private practice and
days. Group B received inj. Ceftriaxone
also to reduce the duration of hospital stay.
100mg/kg/day I/V for 10 days. Repeated
So the objective of the study was to
blood C/S were performed 10 days after
determine the efficacy of Azithromycin
initiation of treatment for those who were
versus Ceftriaxone in the treatment of
positive for S. typhi.
uncomplicated typhoid fever.
Data were collected by interview, physical
METHODS AND MATERIALS:
examinations and laboratory investigations
This was a randomized controlled clinical using a pre-tested structured questionnaire,
trial, conducted at the Department of and were processed and analyzed by
Paediatrics of Shaheed Mansur Ali Medical statistical package for social science (SPSS)
College & hospital, Dhaka, from June 2012 to version 18. P value of <0.05 were taken
December 2012, over 6 (six) months. statistically significant. Protocol of the study
Children 2-12 years old, admitted in the was approved by the IRB of Shaheed Mansur
paediatric ward diagnosed as typhoid fever Ali Medical College & Hospital, Dhaka
on the basis of clinical feature &
RESULTS:
investigation were the study population. A
total of 70 children with enteric fever were This study was undertaken with the
included, and randomly divided by lottery in objective to determine the efficacy of
two groups, Group-A received oral Azithromycin versus Ceftriaxone in the
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P a g e 18
treatment of uncomplicated typhoid fever. A Mean weight of enrolled babies were
total of 70 children, out of whom 35 were 17.3±6.13kgs in Group-A and 17.171 ±
treated with Azithromycin (Group-A) & 35 6.55kgs Group-B (p-0.929). Majority of them
with Ceftriaxone (Group-B), were included 24(68.5%) in Group-A and 23(65.7%) in
in this study. Group-B were between 11-20kgs, and
3(8.6%) in Group-A & 4(11.4%) in Group-B
Mean age of patients in Group-A
were ≤ 10 kg weight. Eight (22.9%) in both
(Azithromycin) was 5.53±3.41years and
groups were >20kgs weight, which was not
5.53± 2.55 years in Group-B (Ceftriaxone)
significant (p-0.798).
(p-1.0). Majority 20(57.1%) in Group-A and
18(51.4%) in Group-B were ≤ 5 years old, Majority in Group-A 19(54.3%) from middle
and 11(31.5%) & 15(42.8%) were between class, 12(34.3%) from lower class and rest
5-10 years in Group-A and Group-B were from upper class. In Group-B
respectively. Rest were >10 years old, which 14(40.0%) each were from middle and
was not significant (p-0.146). Interestingly lower class and rest from upper class (p-
about half of the participants in both groups, 0.083). Socio-economic classes based on
Group-A [17 (48.6%)] and Group-B [18 monthly income (taka per month). Lower
(51.4%)] were Males. Male: Female ratio class: <10,000; Middle class: 10,000-40,000
was about 1:1. (p-0.691). and Upper class: >40,000.

Table-I: Distribution of the children by their presenting complaints

Azithromycin Ceftriaxone
Complaints (n=35) (n=35) Statistical calculations
Percent Percent
Fever 100.0 100.0 RR=1; OR=NA
RR=1.0; 95% CI: 0.9532-1.0491
Immunization 97.1 97.1
OR=1.0; 95% CI: 0.1917-5.2165
RR=0.8185; 95% CI: 0.5263-1.2729
Abdominal pain 25.7 31.4 OR=0.7557; 95% CI: 0.4081-1.3992
χ2 = 0.54; p-value = 0.462433
RR=0.5088; 95% CI: 0.1272-2.0351
Diarrhoea 2.9 5.7
OR=0.4941; 95% CI: 0.1168-2.0893
RR=0.715; 95% CI: 0.3848-1.3286
Constipation 14.3 20.0 OR=0.6674; 95% CI: 0.3172-1.4046
χ2 = 0.78; p-value = 0.377141
GI bleeding 0.0 0.0 RR=NA; OR=NA
Rash 0.0 0.0 RR=NA; OR=NA

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 RR=0; 95% CI: 0-NA
Cough 0.0 2.9
OR=0; 95% CI: 0-NA
Joint pain 0.0 0.0 RR=NA; OR=NA
RR=1.1223; 95% CI: 0.6873-1.8325
Antibiotic before
25.7 22.9 OR=1.1646; 95% CI: 0.6097-2.2244
admission
χ2 = 0.09; p-value = 0.764177
RR=1.1287; 95% CI: 1.052-1.2109
Coated tongue 100.0 88.6 OR=∞; 95% CI: NA-∞
χ2 = 10.06; p-value = 0.001515
RR=1.0; 95% CI: 0.9532-1.0491
Hepatomegaly 97.1 97.1
OR=1.0; 95% CI: 0.1917-5.2165
RR=0.6956; 95% CI: 0.5383-0.8988
Splenomegaly 45.7 65.7 OR=0.4394; 95% CI: 0.2484-0.7772
χ2 = 7.32; p-value = 0.006819
Joint swelling &
0.0 0.0 RR=NA; OR=NA
tenderness
RR=0; 95% CI: 0-NA
Toxic look 0.0 2.9
OR=0; 95% CI: 0-NA
Maculopapular RR=0; 95% CI: 0-NA
0.0 2.9
rash OR=0; 95% CI: 0-NA
RR=0; 95% CI: 0-NA
Dehydration 0.0 2.9
OR=0; 95% CI: 0-NA
Abdominal RR=0.5088; 95% CI: 0.1272-2.0351
2.9 5.7
tenderness OR=0.4941; 95% CI: 0.1168-2.0893
Abdominal
0.0 0.0 RR=NA; OR=NA
distension
Total 100.0 100.0

In both groups fever was present all presentations found among the participants
(100.0%) participants. Most of the patients with almost similar distribution between
were immunized, 97.1% in both groups. groups. About a quarter portion of
Coated tongue, hepatomegaly, participant in each group (25.7% & 22.9%)
splenomegaly, abdominal pain and gave history of receiving antibiotic before
constipation were most notable admission.

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P a g e 20
 Table-II: Distribution of the participants by their Widal test findings

Widal Azithromycin (n=35) Ceftriaxone (n=35)

Statistical calculations
test Percent Percent
RR=1.0297; 95% CI: 0.9708-
Positive 97.1 (34) 94.3 (33)
1.0922
OR=2.0293; 95% CI: 0.4886-
Negative 2.9 (1) 5.7 (2) 8.5581
χ2 = 0.953; p-value =
0.32895685
Total 100.0 100.0
*Inclusion criteria: Positive Widal test & or blood culture

‘Widal test’ was negative in 2.9% of OR=2.0293; 95% CI: 0.4886-8.5581]. The
Azithromycin group and 5.7% of Ceftriaxone difference was not statistically significant
group [RR=1.0297; 95% CI:0.9708-1.0922; (p- 0.328).

Table-III: Distribution of the participants by the Blood culture findings

Blood Azithromycin (n=35) Ceftriaxone (n=35)

Statistical calculations
culture Percent Percent
S. typhi 77.1 (27) 77.1 (27)
No growth 14.3 (5) 8.6 (3) χ2 = 2.838; p-value =
#Not done 8.6 (3) 14.3 (5) 0.24195585
Total 100.0 100.0
#Not done due to refusal of the party and also

Inclusion criteria: Positive Widal test & or period of defervescence was 4.88±0.40 days
blood culture in Group-A and 7.14±0.42 days in Group-B,
which is statistically significant (0.0001). As
Only microorganism found by blood culture
defervescence was achieved before the
was S. typhi.
completion of treatment, both the groups
At the end of treatment, repeated blood in all were discharged in due time, i.e.
the 54 previously culture positive patients Azithromycin group after 7 days and
showed ‘no growth’. Majority 30(85.7%) Ceftriaxone group after 10 days.
patients in Group-A become afebrile
DISCUSSION:
between 5-6 days after start of treatment
and only 5(14.3%) became afebrile <5days. This study was aimed to identify the efficacy
In Group-B majority 34(97.1%) become of Azithromycin versus Ceftriaxone in the
afebrile at ≥7days and only one patient treatment of uncomplicated typhoid fever in
became afebrile between 5-6 days. Mean a tertiary care hospital in Bangladesh. A total
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P a g e 21
of 35 cases (Azithromycin) & 35 controls groups most respondents were from middle
(Ceftriaxone) were included in this study. socio-economic classes. (p-0.083); which
explains there was no significant statistical
In both groups most of the respondents
difference in the groups. Similarly Frenck et
were in the ‘≤ 5 years’ age group; 57.1% in
al. found, demographic and pretreatment
Azithromycin and 51.4% in Ceftriaxone
laboratory evaluation of the subjects
group. Mean age was 5.53±3.41years for
demonstrated that there were no significant
Azithromycin group and 5.53±2.55 years for
differences between the treatment groups.7
Ceftriaxone group (0.146). Frenck et al.
In another study by Frenck et al. analysis of
enrolled total of 64 culture positive children
demographic characteristics and results of
(34 azithromycin recipients and 30
pre-treatment laboratory tests revealed no
ceftriaxone recipients); mean age was 9.7
statistically significant differences between
and 10.1 years respectively.7 In another
patients treated with ceftriaxone and those
study by Frenck et al. 68 patients (32 of
treated with azithromycin.8
whom were in the azithromycin group) had
S. Typhi isolated from cultures of blood or For both Azithromycin group and
stool specimens; Age, mean years ± SD was Ceftriaxone group fever was present in cent
11.8 ± 3.6 and 10.8 ± 3.35.8 percent (100.0%) participants. Most of the
patients were immunized, 97.1% in both
About half of the participants in both
groups. Coated tongue (100.0% & 88.6%),
Azithromycin group [17(48.6%)] and
Hepatomegaly (97.1% & 97.1%),
Ceftriaxone group [18 (51.4%)] were Males.
Splenomegaly (45.7% & 65.7%), Abdominal
In both groups Male: Female ratio was about
pain (25.7% & 31.4%) and Constipation
1:1. (p-0.691). Frenck et al. found 20(58.8%)
(14.3% & 20.0%) were most notable
male in Azithromycin recipients and
presentations found among the participants.
17(56.7%) male among Ceftriaxone
All the presentations showed similar
recipients; male:female ratio was 1.4:1 and
distributions between the two groups and
1.3:1.7 Again, Frenck et al. in another study
there was no significant statistical
found 19(59.4%) male in Azithromycin
difference for any of the factor. Duration of
recipients and 20(55.6%) male among
fever before admission, mean days (range)
Ceftriaxone recipients; male : female ratio
was 9.7 (3–30) and 9.2 (3–15).7 Fever
was 1.46:1 and 1.25:1.8 duration before enrollment, mean days ± SD
More than two-third (68.5%) of the was 10.8±4.5 and 10.8±4.4 respectively.8
Azithromycin group and about two-third of
About a quarter portion of participant in
the Ceftriaxone group (65.7%) weighted ‘11
each group (25.7% & 22.9%) gave history of
to 20 kg’. Both groups showed similar Mean
receiving antibiotic before admission.
± SD for weight (17.30±6.13) and
‘Widal test’ was negative in 2.9% of
(17.17±6.55) kgs. There was no statistically
Azithromycin group and 5.7% of Ceftriaxone
significant difference in distribution of
group [RR=1.0297; 95% CI: 0.9708-1.0922;
weight among the groups (p-0.798). In both

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P a g e 22
OR=2.0293; 95% CI: 0.4886-8.5581]. χ2 the patients were culture negative in both
calculated that the difference was not treatment groups at the end of treatment.
statistically significant (p-0.328). Only
Children of the Azithromycin group became
microorganism found by blood culture was
fever free within 6 days of starting their
S. typhi. About 14% culture report in
treatment; Mean ± SD (4.88±0.40) days and
Azithromycin group and 8.6% in Ceftriaxone
for the Ceftriaxone group most (97.1%)
group yielded ‘no growth’. There was no
required ≥ 7 days; Mean ± SD (7.14±0.42)
statistically significant difference between
days, which was statistically significant (p-
the two groups (p-0.241). That implied that,
0.001). Khan et al.11 found period of
pre-treatment evaluation of the subjects
defervescence in Azithromycin group
demonstrated that there were no significant
5.48±1.24 days and in Ceftriaxone group
differences between the two groups. ‘Blood
5.55±1.29 days. In another study by Khan et
culture’ findings of previously culture
al.12 periods of defervescence in
positive patients 10 days after starting of
Azithromycin group was 5.50±0.91 days and
their treatment, out of 27 participants in
in Ceftriaxone group 5.33±1.09 days, which
each groups none (0.0%) was found to be
is similar to the present study. Similarly, in
positive. In other word, repeated blood
Cairo, Egypt responses to treatment were
culture in all the 54 previously culture
excellent in both groups. Patients responded
positive patients showed ‘no growth’, means
quickly to therapy than the time required by
that, microbiological cure occurred in all
our patients; the mean time to
(100%). At the Abbassia Fever Hospital
defervescence ±SD was 4.1±1.1 days and
cultures of blood specimens obtained from
3.9±1.0 days for azithromycin recipients
64 children (34 azithromycin recipients and
and ceftriaxone recipients, respectively
30 ceftriaxone recipients) were positive for
(P=NS).7 Again in Cairo, Egypt both
S. typhi. Demographic and pre-treatment
antibiotic therapies were highly effective.
laboratory evaluation of the subjects
Mean time (± SD) to defervescence was 4.5
demonstrated that there were no significant
(±1.9) days for patients who received
differences between the two groups.
azithromycin and 3.6 (±1.6) days for
Microbiological cure occurred in 33 (97%)
patients who received ceftriaxone (P = NS).8
of 34 patients treated with azithromycin
The early response than ours, observed by
versus 29 (97%) of 30 patients treated with
this study may be explained by the fact that
ceftriaxone (P = NS).7 At the same centre
in our country, antibiotics are used and sold
again 68 patients (32 in the azithromycin
by unqualified persons at inadequate doses
group) had S. Typhi isolated from cultures of
and duration, which is alarming.
blood or stool specimens obtained at
enrolment and constituted the treatment As defervescence was achieved before the
group. Microbiological cure was achieved in completion of treatment, both the groups
every patient treated with azithromycin and were discharged in due time, i.e.
in 35 (97%) of 36 patients treated with Azithromycin group after 7 days and
ceftriaxone (P-0.5).8 In the present study all
The Planet Volume 03 No. 02 July-December 2019
P a g e 23
Ceftriaxone group after 10 days. In Cairo, literature ciprofloxacin resistant
Egypt clinical cure occurred in 31 (91%) of salmonella enteric serover typhi in India.
34 patients treated with azithromycin, j Infect Developing countries 2008;
compared with 29 (97%) of 30 patients 2:324-27.
treated with ceftriaxone (P = NS).7 Again in
2. Crump JA, Luby SP, Minpz DE. The global
Cairo, clinical cure was achieved in 30 (94%)
burden of typhoid fever. Bulletin of the
of 32 patients treated with azithromycin and
Who Health Organization 2004, 82: 346-
in 35 (97%) of 36 patients treated with
53.
ceftriaxone (P = 0.5).8
3. Black RE, Cisneros L, Levine MM, Banfi A,
CONCLUSION:
Lobos H, Rodriguez H. Case control study
From the present study it can be concluded to identify risk factor for paediatric
that there is no significant difference in endemic typhoid fever in Santiago, Chile.
efficacy of Azythromycin and Ceftriaxone in Bull WHO, 1985; 63:899-904.
treating uncomplicated Typhoid fever.
4. Ferrera KP, Bonasang ES. Azithromycin
Azythromycin took shorter duration to
versus first line antibiotics in the
achieve defervescence, so the total duration
therapeutic management of documented
of hospital stay was also shorter.
case of typhoid fever. Phil j Microbiol
The present study reveals that Infect Dis 2004; 33: 163-68.
Azythromycin and Ceftriaxone can be
5. Girgis NI, Butler T, Frenck RW, Sultan Y,
equally used in case of uncomplicated
Brown FM, Tribble D and Khakhria R.
typhoid fever in children. But this was a
Azithromycin versus ciprofloxacin for
small scale study done at a single centre over
treatment of uncomplicated typhoid
a brief period of time. A large scale, multi-
fever in a randomized trial in Egypt that
centre study over long duration is required
included patients with multidrug
to verify the findings of the present study
resistance. Antimicrobial Agent and
before recommending use of oral
Azythromycin in treating uncomplicated Chemotherapy, 1999; 43: 1441-44.
typhoid fever in children. 6. Rahman AKMM, Ahmad M, Begum RS,
Ghosh AK, Hossain MZ. Multidrug
This study was conducted in a tertiary care
resistant typhoid fever in children. J
hospital in Dhaka city, in a small sample size
of 70 patients, so the findings may not reflect Dhaka Med Coll. 2008; 17: 121-26.
the exact scenario of the country regarding 7. Frenck RW Jr., Nakhla I, Sultan Y, Bassily
typhoid fever. SB, Girgis YF, David J, et al. M
Azithromycin versus Ceftriaxone for the
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