Objective To evaluate the efficacy and safety of ceftazidime-avibactam (CAZ/AVI) in the treatment of Gram-negative bacterial infection. Methods Randomized controlled trial(RCT) on efficacy and safety of CAZ-AVI were retrieved from domestic and foreign databases, clinical cure rate was assessed as the main outcome, microbial clearance rate and incidence of adverse reaction were as secondary outcome, Meta-analysis was performed with Review Manage 5.3. Results Seven RCTs (3 792 patients) were included in Meta-analysis, clinical cure rate of patients at the end of treatment (EOT, RR=0.99, 95% CI=0.96-1.01), at the time of test of cure (TOC, RR=0.99, 95% CI=0.96-1.02), at the time of last follow-up visit (LFU, RR=1.00, 95% CI=0.96-1.03) were not significantly different between CAZ/AVI group and control group (all P>0.05); clinical cure rate at time of TOC of microbiologically modified intention-to-treat (mMITT) of patients was no significantly different between CAZ/AVI group and control group (RR=0.95, 95%CI= 0.89-1.00, P=0.06), control group was better than CAZ/AVI group at EOT (RR=0.95, 95%CI= 0.92-0.98, P=0.005). There was no significant difference in the microbial clearance between CAZ/AVI group and control group at EOT of mMITT of patients (RR=1.00, 95%CI=0.97-1.03) and at time of TOC (RR=1.07, 95%CI=0.92-1.25) (both P>0.05), CAZ/AVI group was better than control group at time of LFU (RR=1.12, 95%CI=1.01-1.23, P=0.03), incidence of adverse reaction and drug withdrawal due to adverse reaction in CAZ/AVI group was basically similar to that in control group, but incidence of serious adverse reaction in CAZ/AVI group was higher than that in control group (RR=1.26, 95%CI=1.01-1.57, P=0.04). Conclusion The efficacy of CAZ/AVI is similar to other antimicrobial agents, which can be used as a alternative medicine for severe infection, considering that incidence of serious adverse reaction is higher than that of other drugs, more high-quality and large-scale studies are needed to demonstrate the safety of CAZ/AVI.